To ensure the development of safe and effective medical devices, the adoption of a design control system is recommended. If you are supplying devices into the EU or US market, design control requirements are outlined in ISO 13485, section 7.3 (EU) and 21 CFR 820.30 Design Control (FDA – US).
While the two standards are quite similar, there are a few items which are unique to the US requirements, such as;
- Independent reviewer on the design review board (DRB)
- System for design transfer
- Device Master Record (21 CFR 820.181)
Design Planning: An overall plan needs to be established in order to plan and control the design of the product. This can be contained in a document called a “Design and Development Project Plan” with headings such as;
- Product Description
- Regulatory Requirements
- Design Inputs
- Design Verification and Validation
- Budgets and Resources
- Design Review, Project Plan (Gantt Charts)
- Training Requirements
- Risk Management
Design Inputs: Design inputs are the various requirements that a product needs to meet, which are transferred into a product requirements specification. They are derived from sources such as functional, performance, user and safety requirements, regulatory requirements, information from previous designs and the outputs of risk management.
Design Outputs: These provide the evidence of a successful design control process and are typically a set of documents such as test results, material specifications, bill of materials, packaging and labelling specifications, manufacturing work instructions, product drawings and acceptance criteria.
Design Review: It is a requirement to carry out formal design review meetings according to planned arrangements. Planned arrangements may indicate a time-bound interval e.g. monthly, or it may correlate with the design stages e.g. a design review meeting takes place in order to move from one design stage to the next. This meeting needs to be documented, with actions detailed, and signatures from the Design Review Board to indicate that the project may proceed to the next stage.
Design Verification and Validation: These activities are related to testing the performance of the device, with some key differences between the activities. Verification relates to confirmation that design outputs meet design inputs e.g. for all the listed design inputs, can we confirm that we met these inputs. Design verification testing is carried out on pre-production batches. Design validation is an assessment if the finished device meetings the user needs and intended use and functions in actual usage conditions. One approach to distinguish both activities is that design verification relates back to the Product Specification Document, whereas design validation relates to the Market Requirement Specification.
Design Changes: Once the project has passed “design freeze” or “design lock”, any changes to the approved design inputs must be processed via a formal change control system. These are referred to as design changes.
If you need any help setting up a design control system, or wish to modify an existing system in order to align with ISO 13485 or FDA controls, please contact us.