Design Control for Medical Devices: Overview and Design Inputs

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 its 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 which is safe and effective and that it meets its design requirements.

Why should you Attend:
In the development of medical device, uncomplete understanding and implementation of design controls will lead to rejection of an application for approval by the FDA or rejection of a CE mark application. Incomplete, improper or missing verification and validation is a cause of many products not being approved for 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.

Areas Covered in the Session:

• Overview of where inputs (requirements) and V&V fit into the general flow of design control
• Regulatory Requirements
• A look at Design Inputs
• Where do they come from
• Flow
• 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