Understanding Design Controls for Medical Devices

Why You Should Attend:

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 as 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 seminar:

• 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

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of consumables and instrumentation in the endoscopy field. In this position, Jeff is responsible for oversight of the quality system, including phase approval of design history files. For the past 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., where he was responsible for corporate compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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