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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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