Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

The Intent Of Regulating Software

Medical Device Safety and Efficacy

Patients

Environment

Operators

Bystanders

Service Personnel

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Many Stakeholders Keeping A Total Solution In Mind

Safety
Patients Operators Bystanders Service People Environment

Medical Practitioners

Customer and Business Needs

All Needs Met

Quality Systems and Q&RA People Doing The Work

Reviewers
Internal Auditors External Reviewers

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Many Stakeholders Keeping A Balanced Solution In Mind

Safety
Patients Operators Bystanders Service People Environment

Medical Practitioners

Customer and Business Needs

All Needs Met

Quality Systems and Q&RA People Doing The Work

Reviewers
Internal Auditors External Reviewers

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Types of Regulated Software

Medical Device Software z Software that is actually a part of the medical device itself z Software that is an accessory to a medical device z Software that itself is a medical device

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Types of Regulated Software

Medical Device Software z Software that is actually a part of the medical device itself z Software that is an accessory to a medical device z Software that itself is a medical device Non-Device Software that is part of: z The production system z The quality system z Systems that are used to create and maintain records required by FDA regulations

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Overview
FDA is a public health agency, charged with:
z

protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws.

It is FDA's job to see that:

z z z z

the food we eat is safe and wholesome, the cosmetics we use won't hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products, such as microwave ovens, won't do us harm

z z

One of our nation's oldest consumer protection agencies. Located in district and local offices in 157 cities across the country
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Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Devices 32,358

11

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Overview
z

Administrative Enforcement Powers

z z z z z z z z

Unannounced and Announced Inspections Inspectional Observations - 483 Warning Letters Adverse Publicity FDA-Initiated Recalls and Monitoring Company-Initiated Recalls Delay, Suspension, or Withdrawal of Product Approvals Preclusion of Government contracts Detention and Refusal of Entry into U.S. Commerce of Imported Products

Judicial Enforcement Powers

z z

Civil Enforcement Powers (Seizure) Criminal Enforcement Powers (Prosecution)

12

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

13

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Device Definition

z

Medical devices range from

z

Simple Devices
z

Tongue depressors and bedpans Programmable pacemakers Laser surgical devices

Complex Devices
z z

Medical Device Classification Class I, II, and III

z z

Class I devices include those with the lowest risk Class III devices includes those with the greatest risk.

14

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Device Definition

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

15

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

16

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

820.30 Design Control

820.30(a) General
z

(1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall:
z

establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
z

(2) The following class I devices are subject to design controls:

(i) Devices automated with computer software; and

(ii) The devices listed .. Below: Catheter, Tracheobronchial Suction Glove, Surgeons Restraint, Protective System, Applicator, Radionuclide, Manual Source, Radionuclide Teletherapy

17

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Special Attention

General Principles of Software Validation 3.3 Software Is Different From Hardware
z

Because of its complexity, the development process for software should be even more tightly controlled than for hardware, in order to prevent problems that cannot be easily detected later in the development process. . software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering.

[1]

18

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

19

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Regulation of Software
Basic Regulatory Requirements Quality System Regulation
A - General Provisions B - Quality System Requirements C Design Controls D Document Controls E Purchasing Controls F Identification and Traceability G Production & Process Controls H Acceptance Activities I Nonconforming Product J Corrective & Preventive Action (CAPA) K Labeling & Packaging Control L Handling, Storage, Distribution & Installation M - Records N - Servicing O Statistical Techniques Design Controls
820.30(a)

General

Establishment Registration

21 CFR 807 21 CFR 807 21 CFR 807 21 CFR 814

Design & Development Planning

820.30(c)

820.30(b)

Design Input
820.30(d)

Medical Device Listing

Design Output
820.30(e)

Premarket Notification 510(k)

Design Review
820.30(f)

Premarket Approval PMA

Design Verification
820.30(g)

Quality System Regulation

21 CFR 820 21 CFR 801

Labeling

Design Validation
820.30(h)

Design Transfer
820.30(i)

Design Changes
820.30 (j)

Medical Device Reporting

21 CFR 803

Design History File20

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Regulation of Software
Basic Regulatory Requirements Quality System Regulation
A - General Provisions B - Quality System Requirements C Design Controls D Document Controls E Purchasing Controls F Identification and Traceability G Production & Process Controls H Acceptance Activities I Nonconforming Product J Corrective & Preventive Action (CAPA) K Labeling & Packaging Control L Handling, Storage, Distribution & Installation M - Records N - Servicing O Statistical Techniques 21 Production & Process Controls
820.70(a)

General

Establishment Registration

21 CFR 807 21 CFR 807 21 CFR 807 21 CFR 814

Production & Process Changes

820.70(c)

820.70(b)

Environmental Control
820.70(d)

Medical Device Listing

Personnel
820.70(e)

Premarket Notification 510(k)

Contamination Control
820.70(f)

Premarket Approval PMA

Buildings
820.70(g)

Quality System Regulation

21 CFR 820 21 CFR 801

Labeling

Equipment
820.70(h)

Manufacturing Material
820.70(i)

Automated Processes

Medical Device Reporting

21 CFR 803

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Regulation of Software
Basic Regulatory Requirements Quality System Regulation
A - General Provisions B - Quality System Requirements C Design Controls D Document Controls E Purchasing Controls F Identification and Traceability G Production & Process Controls H Acceptance Activities I Nonconforming Product J Corrective & Preventive Action Action(CAPA) (CAPA) K Labeling & Packaging Control L Handling, Storage, Distribution & Installation M - Records N - Servicing O Statistical Techniques 22 Corrective & Preventive Action
820.100

Establishment Registration

21 CFR 807 21 CFR 807 21 CFR 807 21 CFR 814

Medical Device Listing

Premarket Notification 510(k)

Quality System Requirements

Premarket Approval PMA

Quality System Regulation

21 CFR 820 21 CFR 801

Labeling

Medical Device Reporting

21 CFR 803

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Regulation of Software
Basic Regulatory Requirements Quality System Regulation
A - General Provisions B - Quality System Requirements C Design Controls D Document Controls E Purchasing Controls F Identification and Traceability G Production & Process Controls H Acceptance Activities I Nonconforming Product J Corrective & Preventive Action (CAPA) K Labeling & Packaging Control L Handling, Storage, Distribution & Installation M - Records N - Servicing O Statistical Techniques 23

Quality System Requirements

820.25(a)

Establishment Registration

21 CFR 807 21 CFR 807 21 CFR 807 21 CFR 814

General

820.25(b)

Training
820.22

Medical Device Listing

Quality Audit

Premarket Notification 510(k)

Premarket Approval PMA

Quality System Regulation

21 CFR 820 21 CFR 801

Labeling

Medical Device Reporting

21 CFR 803

Procedures Medical Product Software Development and FDA Regulations Plans SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design SW Architecture Verification SW Detailed Design SW Detailed Design Verification SW Coding SW Code Verification Unit Test Integration Test SW System Test Beta Testing SW Verification SW Validation COTS Software Components SW Risk/Hazard Analysis SW Human Factors (Use Errors) SW Change Control SW Configuration Management SW Problem Tracking & Resolution SW Traceability Non-Product Software Validation Corrective & Preventive Action (CAPA) Design Transfer Design History File Training Software Quality Audits 24

Software Development Practices and FDA Compliance

Software Basic Requirements

Quality System Regulation
A - General Provisions B - Quality System Requirements C Design Controls D Document Controls E Purchasing Controls F Identification and Traceability G Production & Process Controls H Acceptance Activities I Nonconforming Product J Corrective & Preventive Action (CAPA) K Labeling & Packaging Control L Handling, Storage, Distribution & Installation M - Records N - Servicing O Statistical Techniques

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

25

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Procedures and Plans

Procedures Plans

You must be able to demonstrate that you are

Operating In A State Of Control

Procedures

Plans

Establish, in advance of activities, what you are going to do.

Do what you say you are going to do. Be able to provide objective (documented) evidence.
26

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Development
SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design SW Architecture Verification SW Detailed Design SW Detailed Design Verification SW Coding SW Code Verification
27

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Testing
Unit Test Integration Test SW System Test Beta Testing

28

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Verification & Validation

SW Verification

Engineering Correctness Checks

SW Validation

Intended Use Confirmation

29

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Supporting Processes
COTS Software Components SW Risk/Hazard Analysis SW Human Factors (Use Errors)

SW Change Control SW Configuration Management SW Problem Tracking & Resolution SW Traceability Non-Product Software Validation Corrective and Preventive Action (CAPA)
30

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Release
Design Transfer Design History File

31

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Personnel
Training Software Quality Audits

32

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

33

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality and Software Safety

The Reason

WHY
we need to have a comprehensive and effective Software Development Life Cycle

34

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

The Intent Of Regulating Software

Medical Device Safety and Efficacy

Patients

Environment

Operators

Bystanders

Service Personnel

35

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Understanding Defects

Defects

Start

Development Process

Ship

[2]

36

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Understanding Defects

Defects
Defects Injected

Start

Development Process

Ship

[2]

37

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Understanding Defects

Defects
Defects Injected Defects Detected And Corrected

Defects Shipped

Start

Development Process

Ship

[2]

38

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

A Journey To Fewer Defects

Overall Software Quality

Inject Fewer

Defects

Start

Development Process

Ship

[2]

39

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality Model

Understanding Defect Injection Rates

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Defect injection rates can be reduced by

Performing these activities highly effectively and introducing Causal Analysis
40

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality Model

Understanding Defect Injection Rates

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Defect injection rates will increase if

You do not perform these activities well or you decide not to do the activity at all
41

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality Model

Understanding Defect Injection Rates

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Defect Injection Rates are directly related to the completeness and the effectiveness of each of these activities

42

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality Model

Understanding Defect Injection Rates

100 90 80
Cumulative Defects

70 60 50 40 30 20 10 0
S R ys s eq SW qs Re

Defects Injected

ig n i gn es es D D t HL De

g din Co

st Te t i Un

t In

st Te SW

st l id Te Va s s Sy Sy

ta Be

st Te

m sto Cu

er

Defects per 1000 lines of code

43

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

A Journey To Fewer Defects

Overall Software Quality

Inject Fewer

Defects

Detect More Effectively

Detect Earlier

Start

Development Process

Ship

[2]

44

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality Model

Increasing Effectiveness

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

45

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

A Journey To Fewer Defects

Overall Software Quality

Inject Fewer

Defects

}
Detect More Effectively

Fewer Defects

Zero?

Detect Earlier

Start

Development Process

Ship

[2]

46

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

47

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

Risk/Hazard Analysis Use Error Analysis

Software Requirements

Harm To: Software

High-Level Design

Verification

Patients Operators Bystanders Verification Verification Service Personnel Environment

Software Detailed Design

Software Coding

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

48

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

Risk/Hazard Analysis Use Error Analysis

Software Requirements

Induced By: Software

Verification

Basic Functionality Software Defects Use Errors Verification Verification Environment Interfaces

High-Level Design

Software Detailed Design

Software Coding

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

49

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

50

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

Risk/Hazard Analysis Use Error Analysis

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

51

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

A Continuous Process Throughout the Life Cycle

Risk/Hazard Analysis Use Error Analysis

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

52

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

A Continuous Process Throughout the Life Cycle

Risk/Hazard Analysis Use Error Analysis

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

53

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

A Continuous Process Throughout the Life Cycle

Risk/Hazard Analysis Use Error Analysis

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

54

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Use Error Analysis

User X Error
User Error Blames The User For Doing Something Wrong Use Error Developer takes accountability for developing software that allowed the user to make an error And..the developer incorporates Use Error Analysis into the risk management process resulting in the implementation of built-in safeguards to protect against Use Error
55

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Use Error Analysis

Use Error (Human Factors) Considerations

z z z z z z z z z

Skill Level Variation Environmental Variation Compromising Factors Physical and Sensory Characteristics Perception Cognition Expectancies Mental Models Home Use
56

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

Potential Harm To

Potential Harm To

Potential Harm To

Potential Harm To

Potential Harm To

Patients

Operators

Bystanders

Service Personnel

Environment

Basic Functionality Defects

Use Errors

YES

You are developing a function where the user will be asked to manually enter a patients age You realize that if the age is entered incorrectly that an incorrect diagnosis might be made
57

Environment

Interfaces

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

Function Feature Patient Age Entry

Potential Event Incorrect Age Entered

(Use Error)

Potential Hazard Incorrect Diagnosis

Severity Major

Control Mitigation Enter Date of Birth (cross check)

Post Control Severity Acceptable

V&V Test Procedure 58 12345

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Safety Model

Risk/Hazard Analysis & Use Error Analysis

59

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

60

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Recall Statistics
Software Related Recalls
Initial (21%) Due To Changes (79%)

FDA Analysis 3140 Recalls (1992 1998) Software-related recalls 242 Software recalls due to changes 192 (79%)
Of those software related recalls, 192 (or 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution FDA Guidance (2002) General Principles of Software Validation
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Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Maintenance Challenges

Oversimplification of the task Customer and Patient expectations Increased requirements on system Changes Design additions and/or modifications State of the documentation Knowledge level Personnel changes Software components (COTS) Hardware components Interfaces Cybersecurity issues Maintenance Challenges
62

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Creating A Balance
Processes Requirements management Anomaly management Technology transition management Risk management Training Change control Software development life cycle Technical reviews Validation planning Testing Configuration management Documentation updates
63

Challenges Oversimplification of the task Customer and Patient expectations Increased requirements on system Changes Design additions and/or modifications State of the documentation Knowledge level Personnel changes Software components (COTS) Hardware components Interfaces Cybersecurity issues

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

64

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Corrective Action Preventive Action (CAPA)

Same Product Similar Problems? Investigate Find Root Cause Problem Encountered Correct The Problem Investigate Find Root Cause Correct The Problem

Other Products Similar Problems? Investigate Find Root Cause Correct The Problem

Process Change Prevent Similar Problems From Occurring In The Future

65

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

66

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Quality System Regulation

The Regulation The Quality System Regulation 21 CFR 820

Design Control Guidance

Medical Device Quality System Manual

FDA General References Medical Device Quality System Manual

Design Control Guidance Do It By Design Medical Device Use Safety (Human Factors/Use Errors) Guide To Inspections Of Quality Systems (QSIT)

Do It By Design

Medical Device Use Safety Human Factors Risk Mgmnt

Guide To Inspections Of Quality Systems (QSIT)

General Principles of Software Validation

Software Pre-Market Submission Guidance

Off-The-Shelf Software Guidance

FDA Software Specific References

General Principles of Software Validation Software Pre-market Submission Guidance Off-The-Shelf Software Guidance
ISO 14971

ANSI/AAMI SW68:2001 Software Processes

ISO 62304

ISO 13485

Industry References ISO 13485 ANSI/AAMI SW68

ISO 62304 ISO 14971

67

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

General Principles of Software Validation

Software Pre-Market Submission Guidance

Off-The-Shelf Software Guidance

FDA Software Specific References

General Principles of Software Validation Software Pre-market Submission Guidance Off-The-Shelf Software Guidance

ANSI/AAMI SW68:2001 Software Processes

ISO 62304

Industry References ANSI/AAMI SW68

ISO 62304

68

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Software-Specific Guidance Documents

69

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Software-Specific Guidance Documents

70

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

ANSI/AAMI SW68:2001 Medical Device Software - Software life cycle processes

71

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

AAMI TIR32:2004 Medical device software risk management

72

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Website

www.fda.gov

Click On Medical Devices

73

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Website

CDRH A-Z Index

Click On CDRH A-Z Index

74

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Website

Click On S For Software

75

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Website

Scroll Down To Software

76

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Website

77

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

FDA Website
http://www.fda.gov/cdrh/humanfactors/

78

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

AAMI Website

www.aami.org

79

Procedures Medical Product Software Development and FDA Regulations Plans SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design SW Architecture Verification SW Detailed Design
Medical Device Quality System Manual Design Control Guidance General Principles of Software Validation Software Pre-Market Submission Guidance Off-The-Shelf Software Guidance

Software Development Practices and FDA Compliance

SW Detailed Design Verification SW Coding SW Code Verification Unit Test

ANSI/AAMI SW68:2001 Software Processes

Do It By Design Quality System Regulation

Medical Device Use Safety Human Factors Risk Mgmnt

Integration Test SW System Test Beta Testing SW Verification SW Validation COTS Software Components SW Risk/Hazard Analysis SW Human Factors (Use Errors) SW Change Control SW Configuration Management SW Problem Tracking & Resolution SW Traceability Non-Product Software Validation Corrective & Preventive Action (CAPA) Design Transfer Design History File Training Software Quality Audits 80

Guide To Inspections Of Quality Systems (QSIT)

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Medical Product Software Development and FDA Regulations

Introduction Regulated Software FDA Overview Medical Device Definition Software Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion

81

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Software Quality Model

Risk/Hazard Analysis Use Error Analysis

CAPA

Low Defect Injection Rates

Software Requirements

Software High-Level Design

Software Detailed Design

Software Coding

Verification

Verification

Verification

Verification

Early and Highly Effective Defect Detection Steps

Unit Test

Integration Test

Software System Test

System Validation

Beta Site Testing

Customer

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Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Its All About Making It Safe Your Families! - Your Loved Ones! - Your Friends! Each and Every One Of YOU!
Patients Environment

Operators

Bystanders

Service Personnel

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Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

Carl R. Wyrwa [email protected] MedicalDeviceSoftware.com

UC Irvine Extension Program

Medical Product Development Medical Device Engineering BME X401 Software-Controlled Medical Devices Software Engineering & Compliance
http://unex.uci.edu/certificates/life_sciences/medical_products/details.asp
84

Medical Product Software Development and FDA Regulations

Software Development Practices and FDA Compliance

References
[1] FDA (2002). General Principles of Software Validation; Final Guidance for Industry and FDA Staff. FDA website: http://www.fda.gov/cdrh/comp/guidance/938.pdf [2] Pietrasanta, Alfred M. (1990). Defect Prevention. Software Quality Improvement Module 9: Software Engineering Institute, Carnegie Mellon University.

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