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Procedure for Design and Development

This document outlines the procedure for design and development of medical devices in compliance with ISO 13485:2016. It details the responsibilities of various teams, the stages of design and development, and the necessary documentation and records required throughout the process. The procedure includes planning, inputs, outputs, reviews, verification, validation, transfer, and change control activities.

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13 views8 pages

Procedure for Design and Development

This document outlines the procedure for design and development of medical devices in compliance with ISO 13485:2016. It details the responsibilities of various teams, the stages of design and development, and the necessary documentation and records required throughout the process. The procedure includes planning, inputs, outputs, reviews, verification, validation, transfer, and change control activities.

Uploaded by

rengasri13953
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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PROCEDURE FOR DESIGN AND DEVELOPMENT


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CHAPTER TOPIC PAGE NO

1. PURPOSE 4

2. SCOPE 4

3. USERS OR RESPONSIBILITY 4

4. PROCEDURE 4

5. RECORDS 6

6. REFERENCES 6

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LIST OF ANNEXURES

ANNEXURE
NO. DESCRIPTION
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

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1. PURPOSE
This procedure outlines the systematic approach for planning, executing, reviewing,
verifying, validating, transferring, and controlling design and development activities for
medical devices in compliance with ISO 13485:2016 requirements.

2. SCOPE
This procedure applies to all design and development projects related to medical devices
within the organization, including new product development and design changes.

3. RESPONSIBILITIES
 Design Manager: Overall responsibility for planning and managing design
activities.
 Project Team: Execute assigned design tasks, ensure documentation and
traceability.
 QA Team: Ensure compliance with quality and regulatory requirements.
 Regulatory Affairs: Ensure design meets applicable regulatory requirements.
 Production Representative: Ensure manufacturability of the product during
development and transfer stages.

4. PROCEDURE
4.1 DESIGN AND DEVELOPMENT PLANNING

 Document the stages of design and development.


 Identify reviews at each stage.
 Specify verification, validation, and transfer activities.
 Assign responsibilities and authorities.
 Establish traceability of outputs to inputs.
 Define required resources and personnel competencies.
 Update plans as design progresses.

4.2 DESIGN AND DEVELOPMENT INPUTS

 Determine functional, performance, usability, and safety requirements.


 Include regulatory and standards compliance.
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 Incorporate risk management outputs.


 Refer to previous design experience where applicable.
 Verify inputs are complete, unambiguous, and non-conflicting.

4.3 DESIGN AND DEVELOPMENT OUTPUTS

 Ensure outputs meet input requirements.


 Include data for procurement, production, and service.
 Define product acceptance criteria.
 Describe essential product characteristics.
 Maintain approval records of outputs before release.

4.4 DESIGN AND DEVELOPMENT REVIEW

 Conduct systematic reviews at defined stages.


 Evaluate results against requirements.
 Include cross-functional team members.
 Record results, participants, and necessary actions.

4.5 DESIGN AND DEVELOPMENT VERIFICATION

 Verify outputs meet input requirements using documented plans.


 Include methods, acceptance criteria, and statistical rationale.
 Include interface verification if device connects to others.
 Maintain records of verification results and conclusions.

4.6 DESIGN AND DEVELOPMENT VALIDATION

 Validate product for intended use through planned activities.


 Conduct validation using representative product samples.
 Perform clinical/performance evaluations as per regulations.
 Include interface validation when applicable.
 Record results, conclusions, and rationale.

4.7 DESIGN AND DEVELOPMENT TRANSFER

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 Ensure outputs are suitable for manufacturing before finalization.


 Verify production capability meets product requirements.
 Maintain records of transfer activities and conclusions.

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4.8 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

 Identify and document all changes.


 Review changes for impact and regulatory implications.
 Verify and validate changes where required.
 Approve changes before implementation.
 Evaluate effect on in-process or delivered products.
 Maintain records of change control activities.

4.9 DESIGN AND DEVELOPMENT FILE

 Maintain a file for each device type or family.


 Include or reference records demonstrating conformity to design requirements.
 Maintain change control documentation in the design file.

5. RECORDS

 Design and Development Plans


 Design Inputs and Outputs
 Design Review Reports
 Verification and Validation Reports
 Change Control Forms and Impact Assessments

6. REFERENCES

 ISO 13485:2016 – Quality Management Systems for Medical Devices


 ISO 14971 – Risk Management for Medical Devices
 Organization’s SOP on Design Controls

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