Procedure for Design and Development
1. Purpose
To establish a systematic approach for the planning, execution, verification, and
validation of medical device design and development activities to ensure compliance with
ISO 13485:2016 and applicable regulatory requirements.
2. Scope
This procedure applies to all design and development activities of medical devices carried
out by the organization, including new product development, product modifications, and
design improvements.
3. Responsibilities
Design and Development Manager: Responsible for overall management of design
and development activities, ensuring that all stages are properly executed and
documented.
Project Team: Executes specific design tasks, prepares design documentation, and
participates in reviews and validations.
Quality Assurance: Ensures compliance with quality management and regulatory
requirements through reviews, audits, and documentation control.
Regulatory Affairs: Provides input on regulatory requirements and ensures that design
documentation meets external compliance standards.
4. Definitions
Design Input: Documented physical and performance requirements that are used as a
basis for device design.
Design Output: Results of design activities that define product features and
characteristics.
Design Review: Planned and documented formal evaluation of design results against
requirements.
Design Verification: Process of evaluating whether design outputs meet design input
requirements.
Design Validation: Process of evaluating whether the final product meets user needs
and intended use.
5. Procedure
1. 5.1 Design and Development Planning
A Design and Development Plan must be created at the initiation of a project,
outlining phases, milestones, responsible personnel, review points, and required
documentation.
The plan must be reviewed and approved by the Design and Development
Manager and updated throughout the lifecycle of the project.
Interfaces between different departments must be defined and managed to ensure
effective communication and input.
2. 5.2 Design Inputs
Collect inputs from customer requirements, regulatory standards, risk
assessments, previous design data, and market analysis.
Inputs must be reviewed for clarity, completeness, and feasibility before being
finalized.
Design inputs should be traceable and approved by the relevant stakeholders.
3. 5.3 Design Outputs
Develop detailed design documentation including drawings, schematics, technical
specifications, manufacturing instructions, and inspection criteria.
Ensure that design outputs fulfill input requirements and are suitable for
manufacturing and servicing.
Outputs must be reviewed, approved, and baselined before release.
4. 5.4 Design Review
Conduct design reviews at planned stages such as concept, preliminary design,
detailed design, and final design.
Reviews must involve cross-functional teams to evaluate progress, identify issues,
and ensure compliance.
Document outcomes, actions required, and responsible persons for follow-up.
5. 5.5 Design Verification
Develop verification protocols based on design input requirements using methods
such as inspections, tests, and simulations.
Verification activities should be documented and results reviewed by QA to
ensure compliance.
Any discrepancies found must be addressed with corrective actions before moving
forward.
6. 5.6 Design Validation
Perform validation under conditions that simulate actual use to ensure the product
meets user needs.
Use usability studies, clinical evaluations, or field testing as appropriate to
validate the final design.
Validation must be documented, and the product must be approved before
commercial release.
7. 5.7 Control of Design and Development Changes
All changes must be reviewed for impact on form, fit, function, regulatory
compliance, and manufacturing processes.
Maintain records of changes, justifications, approvals, and
re-verification/validation where required.
Communicate approved changes to all relevant departments and update associated
documentation.
6. Records
Design and Development Plans
Design Inputs and Outputs
Design Review Reports
Verification and Validation Reports
Change Control Forms and Impact Assessments
7. References
ISO 13485:2016 – Quality Management Systems for Medical Devices
ISO 14971 – Risk Management for Medical Devices
Organization’s SOP on Design Controls
