Design Control for Medical Devices Including Verification/Validation
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.
WHY SHOULD YOU ATTEND?
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.
LEARNING OBJECTIVES
- Overview of where inputs (requirements) and V&V fit into the general flow of design control
- Regulatory Requirements
- A look at Design Inputs
1) Where do they come from
2) Flow
3) Traceability
- Verification of Product Requirements
- Validation of User Needs
- Trace matrix and summary reports
- Conclusions
WHO WILL BENEFIT?
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
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.
- Overview of where inputs (requirements) and V&V fit into the general flow of design control
- Regulatory Requirements
- A look at Design Inputs
1) Where do they come from
2) Flow
3) Traceability
- Verification of Product Requirements
- Validation of User Needs
- Trace matrix and summary reports
- Conclusions
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
Speaker Profile
Alan M Golden
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 …
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