SOP_PMS

The Standard Operating Procedure (SOP) outlines the Post-Market Surveillance (PMS) process for the Nadi Diagnostic Device, detailing the collection and analysis of post-market data. It applies to all marketed devices and assigns responsibility to Regulatory Affairs and Quality Assurance. Key procedures include collecting user feedback, logging complaints, reviewing reports, and maintaining documentation for corrective actions.

Uploaded by

vishal

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

0% found this document useful (0 votes)

0 views

SOP_PMS

Uploaded by

vishal

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

You are on page 1/ 1

Standard Operating Procedure (SOP)

Title: Post-Market Surveillance (PMS)

Document No.: SOP/PMS/001

Version: 1.0

Effective Date: [Insert Date]

1. Objective

To define the procedure for collecting, analyzing, and acting upon post-market data for the Nadi

Diagnostic Device.

2. Scope

Applicable to all marketed Nadi Diagnostic Devices.

3. Responsibility

Regulatory Affairs and Quality Assurance.

4. Procedure

- Collect user feedback.

- Log all complaints and malfunctions.

- Review reports periodically.

- Take corrective and preventive action.

5. Documentation

Maintain PMS report and CAPA records.

REG.8.2-01-00 Post-Market - Surveillance - Plan - # - 2019 - 02 - 04 - # - V2
67% (3)
REG.8.2-01-00 Post-Market - Surveillance - Plan - # - 2019 - 02 - 04 - # - V2
4 pages
Laboratory Quality/Management: A Workbook with an Eye on Accreditation
From Everand
Laboratory Quality/Management: A Workbook with an Eye on Accreditation
Kenneth N. Parson
5/5 (2)
Project Management of Clinical Trials
From Everand
Project Management of Clinical Trials
Richard Chamberlain
No ratings yet
Guidelines for Auditing Process Safety Management Systems
From Everand
Guidelines for Auditing Process Safety Management Systems
CCPS (Center for Chemical Process Safety)
No ratings yet
Operationalizing Information Security: Putting the Top 10 SIEM Best Practices to Work
From Everand
Operationalizing Information Security: Putting the Top 10 SIEM Best Practices to Work
Scott Gordon
No ratings yet
The Operational Auditing Handbook: Auditing Business and IT Processes
From Everand
The Operational Auditing Handbook: Auditing Business and IT Processes
Andrew Chambers
4.5/5 (5)
Information Systems Auditing: The IS Audit Testing Process: Information Systems Auditing, #3
From Everand
Information Systems Auditing: The IS Audit Testing Process: Information Systems Auditing, #3
Robert E. Davis
1/5 (1)
Guide to Audit Data Analytics
From Everand
Guide to Audit Data Analytics
AICPA
No ratings yet
Risk Assessment for Asset Owners
From Everand
Risk Assessment for Asset Owners
Alan Calder
4.5/5 (3)
Periodic Safety Update Report: Product
0% (1)
Periodic Safety Update Report: Product
5 pages
Guidelines for the Management of Change for Process Safety
From Everand
Guidelines for the Management of Change for Process Safety
CCPS (Center for Chemical Process Safety)
No ratings yet
A Guide to Effective Internal Management System Audits: Implementing internal audits as a risk management tool
From Everand
A Guide to Effective Internal Management System Audits: Implementing internal audits as a risk management tool
Andy Nichols
3/5 (5)
Introduction to Quality by Design for Pharmaceuticals
From Everand
Introduction to Quality by Design for Pharmaceuticals
Nilesh Desai
No ratings yet
EU NB-MED - 2.12 - Rec1 - Rev 11 - Post-Marketing Surveillance - PMS
100% (1)
EU NB-MED - 2.12 - Rec1 - Rev 11 - Post-Marketing Surveillance - PMS
9 pages
Medical Devices and IVDs: Fit for the new EU-Regulations: Your complete seminar for projekt, study and job
From Everand
Medical Devices and IVDs: Fit for the new EU-Regulations: Your complete seminar for projekt, study and job
Wolfgang Ecker
No ratings yet
PST Marketing Surveilance Plan Example
No ratings yet
PST Marketing Surveilance Plan Example
4 pages
Post MarketSurveillancePlanTemplate
100% (2)
Post MarketSurveillancePlanTemplate
3 pages
Post Market Surveillance Plan
No ratings yet
Post Market Surveillance Plan
5 pages
Laboratory Practice Quality Pocket handbook
From Everand
Laboratory Practice Quality Pocket handbook
Samuel Mabusela
No ratings yet
Post Market Surveillance Plan
No ratings yet
Post Market Surveillance Plan
6 pages
O-TTPS: for ICT Product Integrity and Supply Chain Security – A Management Guide
From Everand
O-TTPS: for ICT Product Integrity and Supply Chain Security – A Management Guide
Sally Long
No ratings yet
31 Post Market Surveillance
No ratings yet
31 Post Market Surveillance
5 pages
Guidelines to make your own SOP (Standard Operating Procedure)): 1, #1
From Everand
Guidelines to make your own SOP (Standard Operating Procedure)): 1, #1
Reaz
No ratings yet
Essential Managed Healthcare Training for Technology Professionals (Volume 2 of 3) - Bridging The Gap Between Healthcare And Technology For Software Developers, Managers, BSA's, QA's & TA's
From Everand
Essential Managed Healthcare Training for Technology Professionals (Volume 2 of 3) - Bridging The Gap Between Healthcare And Technology For Software Developers, Managers, BSA's, QA's & TA's
Steve Bate, Ph.D.
No ratings yet
Sop Post Market Surveillance
No ratings yet
Sop Post Market Surveillance
3 pages
The Concise Calibration & Test Equipment Management Guide: The Concise Collection, #1
From Everand
The Concise Calibration & Test Equipment Management Guide: The Concise Collection, #1
Adrian Brown
4.5/5 (2)
Post-Market Surveillance The Ultimate Guide under MDR
No ratings yet
Post-Market Surveillance The Ultimate Guide under MDR
8 pages
Practical Guide To Production Planning & Control [Revised Edition]
From Everand
Practical Guide To Production Planning & Control [Revised Edition]
Kerwin Mathew
1/5 (1)
Sop Post Market Surveillance
100% (1)
Sop Post Market Surveillance
3 pages
Guidelines for Asset Integrity Management
From Everand
Guidelines for Asset Integrity Management
CCPS (Center for Chemical Process Safety)
5/5 (1)
Incident Management Process Guide For Information Technology
From Everand
Incident Management Process Guide For Information Technology
Carlo Figliomeni B.B.M.
No ratings yet
The Art and Science of Auditing: Principles, Practices, and Insights
From Everand
The Art and Science of Auditing: Principles, Practices, and Insights
Naila Hina
No ratings yet
Procuring Penetration Testing Services
From Everand
Procuring Penetration Testing Services
CREST
No ratings yet
Vending Machine Route Planning Strategies Plan
From Everand
Vending Machine Route Planning Strategies Plan
Business Success Shop
No ratings yet
Operational Risk & Control (ORC) Best Practice Framework
From Everand
Operational Risk & Control (ORC) Best Practice Framework
JOHN KABAA KAMAU
No ratings yet
Operational Risk & Control (ORC) Best Practice Framework
From Everand
Operational Risk & Control (ORC) Best Practice Framework
John Kabaa
No ratings yet
Food Control System Assessment Tool: Dimension D – Science/Knowledge Base and Continuous Improvement
From Everand
Food Control System Assessment Tool: Dimension D – Science/Knowledge Base and Continuous Improvement
Food and Agriculture Organization of the United Nations
No ratings yet
The Datadog Handbook: A Guide to Monitoring, Metrics, and Tracing
From Everand
The Datadog Handbook: A Guide to Monitoring, Metrics, and Tracing
Robert Johnson
No ratings yet
Stress Free Maintenance Solutions
From Everand
Stress Free Maintenance Solutions
Ron Mueller
No ratings yet
Corrective Action and Preventive Action (CAPA) in Pharmaceutical Industry
From Everand
Corrective Action and Preventive Action (CAPA) in Pharmaceutical Industry
Chandrasekhar Panda
No ratings yet
Role and Responsibility of Pharmaceutical Industry Plant Personnel
From Everand
Role and Responsibility of Pharmaceutical Industry Plant Personnel
Chandrasekhar Panda
No ratings yet
Post Market Surveillance Plan
No ratings yet
Post Market Surveillance Plan
5 pages
Framework for SCADA Cybersecurity
From Everand
Framework for SCADA Cybersecurity
Richard Clark
5/5 (1)
sop-post-market-surveillance
No ratings yet
sop-post-market-surveillance
4 pages
Audit Engagement Strategy (Driving Audit Value, Vol. III): The Best Practice Strategy Guide for Maximising the Added Value of the Internal Audit Engagements
From Everand
Audit Engagement Strategy (Driving Audit Value, Vol. III): The Best Practice Strategy Guide for Maximising the Added Value of the Internal Audit Engagements
Hans Beumer
No ratings yet
The Maintenance-Excellence Program
From Everand
The Maintenance-Excellence Program
Kris Bagadia
3/5 (2)
Quality Control Management in Focus
From Everand
Quality Control Management in Focus
Jerry H. Swift
No ratings yet
CISSP - Certified Information Systems Security Professional Exam Preparation Study Guide
From Everand
CISSP - Certified Information Systems Security Professional Exam Preparation Study Guide
Georgio Daccache
5/5 (1)
Audit Risk Alert: Government Auditing Standards and Single Audit Developments: Strengthening Audit Integrity 2018/19
From Everand
Audit Risk Alert: Government Auditing Standards and Single Audit Developments: Strengthening Audit Integrity 2018/19
AICPA
No ratings yet
Earned Value Management: A Global and Cross-Industry Perspective on Current EVM Practice
From Everand
Earned Value Management: A Global and Cross-Industry Perspective on Current EVM Practice
Lingguang Song
No ratings yet
Regulatory Oversight of Ageing Management and Long Term Operation Programme of Nuclear Power Plants
From Everand
Regulatory Oversight of Ageing Management and Long Term Operation Programme of Nuclear Power Plants
IAEA
No ratings yet
Introduction to N.C.M., a Non Contact Measurement Tool
From Everand
Introduction to N.C.M., a Non Contact Measurement Tool
Dennis R. Branch
No ratings yet
Concise Guide to CompTIA Security +
From Everand
Concise Guide to CompTIA Security +
alasdair gilchrist
3/5 (2)
The Duty for Sponor Oversight in Clinical Trials: Practical Guide: 2nd Edition Clinical Data Review
From Everand
The Duty for Sponor Oversight in Clinical Trials: Practical Guide: 2nd Edition Clinical Data Review
Doris Breiner
No ratings yet
Building a Cannabis Testing Laboratory: A comprehensive guide
From Everand
Building a Cannabis Testing Laboratory: A comprehensive guide
Javier Diaz
No ratings yet
Penetration Testing Services Procurement Guide
From Everand
Penetration Testing Services Procurement Guide
CREST
No ratings yet
Software Testing Interview Questions You'll Most Likely Be Asked
From Everand
Software Testing Interview Questions You'll Most Likely Be Asked
Vibrant Publishers
No ratings yet
SAFETY IN PETROLEUM FACILITIES TURNAROUND MAINTENANCE
From Everand
SAFETY IN PETROLEUM FACILITIES TURNAROUND MAINTENANCE
Chidi V. Efobi
No ratings yet
Testing Practitioner Handbook
From Everand
Testing Practitioner Handbook
Renu Rajani
No ratings yet
Ultimate Guide-to-Postmarket-Surveillance-of-Medical-Devices
No ratings yet
Ultimate Guide-to-Postmarket-Surveillance-of-Medical-Devices
27 pages

SOP_PMS

Uploaded by

SOP_PMS

Uploaded by

Standard Operating Procedure (SOP)

Title: Post-Market Surveillance (PMS)

Document No.: SOP/PMS/001

Effective Date: [Insert Date]

Applicable to all marketed Nadi Diagnostic Devices.

Regulatory Affairs and Quality Assurance.

- Collect user feedback.

- Log all complaints and malfunctions.

- Review reports periodically.

- Take corrective and preventive action.

Maintain PMS report and CAPA records.

You might also like