Design Control for Medical Device Professionals

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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Design Control for Medical Device Professionals

Design Control for Medical Device Professionals

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Instructor : Jeff Kasoff

Product Id : 600211

Overview: 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.Â This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be deisgn 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

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

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