Design and development for medical devices has to fulfill all essential performance and product requirements to finally meeting end customer needs. Developers face the challenge to find appropriate technical solutions, ensure product safety, and establish risk controls on potential product defects while also deal with all relevant regulations.
ISO 13485:2016 helps to carry out medical device design activities in an effective and controlled manner. It is an ideal blueprint to ensure that the leap from design to development is done in a structured way. With its new requirements for design and development, it has not only made the process safer for implementing organizations, it now also aligns perfectly to the FDA design control requirements.
Technically, "design controls" is an FDA term and defined in the FDA quality system regulation (QSR) 21 CFR 820.30. It is basically a system of checks and balances to make systematic assessments of the design an integral part of the development. In ISO 13485:2016, the terminology and intent are similar. Section 7.3 Design and Development now contains all the essential design control elements as requirements for product realization.
- You gain valuable insights into the key steps of a design development process meeting ISO 13485:2016 as well as FDA QSR requirements.
- You understand the purpose and intent of design controls, how to address them in a meaningful way and how they benefit your medical devices development efforts.
- You are guided through the design and development process step by step on the basis of practical examples.
- You get industry best-practice tips how to efficiently establish design and development documents along the process.
- Design and development process: Slim but helpful. Key elements to help controlling all major development activities.
- Design and development planning: As much as necessary, as less as possible with focus on design control and enough leeway for development.
- Design and development input: No more “garbage in – garbage out”. Roadmap to make design input complete, unambiguous, non-conflicting and able to be verified or validated.
- Design and development output: That is what the customer gets. How to transform all the design solutions into a good recipe for making the medical device at the end.
- Design and development review: Trust is a good thing, but control is a better one. How to make it a beneficial event for the design and the review team.
- Design and development verification and validation: The climax of all development efforts and the moment of truth. How to prove that the right medical device was developed the right way.
- Design and development transfer: Just before the finish line. How to ensure everything that is needed for production is ready and done.
- Control of design and development changes: Change is a chance for improvement. How to control necessary changes without having to starting from scratch.
- Design and development files
- Design history file (DHF): This is the place to look for objective evidence that the medical device developed is safe, effective and meets the intended use. How to make it a real good history.