Jeff Kasoff 2012 - Understanding Design Controls for Medical Devices

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.

Areas Covered in the Session:

- History of design control

- Design planning

- Design input/output

- Design reviews

- Design documentation

- Design transfer

- In-process design control

Who will benefit:

This webinar will provide valuable assistance to all companies that perform design activities. The employees who will benefit include:

R&D personnel and management

Process and Quality Engineers

QA management

Consultants

Quality system auditors

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