Design Control for Medical Devices Including Verification/Validation
Duration: 60 Minutes
Verification and validation of design inputs is a critical step in the development of medical devices.
It is the objective evidence that the developer developed what they set out to develop and the final product meets the design goals and needs of the end user. Without proper verification/validation of inputs, it is not possible to prove to regulatory agencies that you have a product that is safe and effective and that it meets its design requirements.
- Overview of where inputs (requirements) and V&V fit into the general flow of design control
- Regulatory Requirements
- A look at Design Inputs
2) Flow
3) Traceability
- Verification of Product Requirements
- Validation of User Needs
- Trace matrix and summary reports
- Conclusions
In the development of medical devices, incomplete understanding and implementation of design controls will lead to the rejection of an application for approval by the FDA or the rejection of a CE mark application. Incomplete, improper, or missing verification and validation is a cause of many products not being approved for the market. This seminar will give the participants the basics to be able to work through the concepts of design verification/validation and implement these concepts in their respective areas.
This Webinar is appropriate to Anyone Working in Design, Development, Marketing or Support of Regulated Medical Devices
People working in R&D, Quality Assurance, Validation, Regulatory Affairs, Marketing, Production and Product Support will Benefit from this Information
People working in R&D, Quality Assurance, Validation, Regulatory Affairs, Marketing, Production and Product Support will Benefit from this Information
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation, and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops, and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
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