Design and Development Process for Medical Devices
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The design and development process for medical devices is complex and multifaceted. It must meet relevant regulations, product safety standards, and risk controls, in addition to usual application requirements, specification requirements, and end customer needs. The criticality of this process lies in the fact that if a medical device fails to meet regulatory design requirements, it cannot reach the market.
An improper design in medical devices can be hazardous to patients and may lead to product rejection by regulatory bodies. This can damage the reputation of the medical device supplier. ISO 13485:2016 helps manage medical device design activities effectively and in a controlled manner.
Design and Development Process Management
ISO 13485:2016 introduces new requirements within the scope of design and development, such as design and development transfer records and design files.
Key Requirements for Design and Development
Procedure
Document all logical phases in design and development in a well-structured procedure.
Define responsibilities for different activities, including approving authorities.
Planning
Identify goals and objectives of design and development.
Break down major activities, including risk management.
Allocate resources needed in each phase.
Inputs
Intended Application
Usability Requirements: Application, preservation, handling, and maintenance.
Customer and End User Requirements
Physical Features and Manufacturing Feasibility
Ergonomics and Safety Factors
Risk Control and Mitigation Techniques
Past Complaints and Failure Reports
Regulatory, Legal, and Statutory Needs
Sterilization Requirements
Economic Study and Costing Feasibility
Outputs
Specifications in drawings.
Manufacturing process and environmental specifications.
Quality assurance procedures.
Product identification and traceability.
Documentation for regulatory authorities.
Design history file.
Review
Address manufacturing and customer concerns.
Demonstrate design meets product requirements.
Ensure compatibility with processing capabilities and safety concerns.
Maintain minutes of design reviews.
Verification
Ensure design outputs meet input requirements.
Verify designs through tests, calculations, inspections, and document reviews.
Validation
Confirm that the medical device meets end user requirements.
Validate on samples from initial lots in simulated conditions.
Maintain records of design validation.
Transfer
Document a procedure to transfer design outputs to manufacturing.
Ensure design can be translated to production.
Control of Changes
Include a mechanism to control design changes.
Review, verify, validate, and approve changes before enforcement.
Design and Development Files
Maintain a file for each medical device design.
Include records of conformity to design requirements, review, verification, validation, and changes.
Helping Organizations with an Effective Design and Development Process
ISO 13485:2016, with its new requirements for design and development, ensures a safer and more effective process. The design manufacturing process is critically reviewed at every step for shortcomings. Design flaws are corrected on factors such as device safety, market competitiveness, regulatory consent, user satisfaction, functional usability, and profit returns. Improvements are incorporated into the approved design.
ISO 13485 design and development guidelines play a vital role in the medical device lifecycle. They add value for end users, patients, and hospitals, and fulfill the needs of regulators. Medical device manufacturers and suppliers can greatly benefit from adhering to these guidelines.
