Risk Management as applied to Design Control

The FDA has strict regulations to ensure that the design of a medical device is properly planned, executed, reviewed, and documented (21CFR820.30). Yet, there is no such structure for risk management; how a company performs risk management is not regulated. However, in the last decade the FDA is placing more and more emphasis on risk management, and requires companies to report their risk management efforts as part of 510(k) and PMA submissions. In this introductory webinar you will learn how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.

Areas Covered in the seminar:

• The difference between risk analysis and risk management.
• Definitions: harm, hazard, risk, verification.
• The methodology of risk management.
• The methodology of design control per 21CFR820.30
• How to apply the requirements of ISO14971 to the design control process.
• The deliverables: what documentation to generate, and when.

Who will benefit:

This webinar is of value to every company in the medical device field that designs products. This includes "Specification Developers" as defined by the FDA. The employees who will benefit include:

• R&D and Engineering managers and personnel
• QA managers and personnel
• Test and Service managers and personnel
• Validation specialists
• Consultants
• Quality system auditors

Instructor Profile:

Nicolaas Besseling, MSEE, is the founder and President of BesTech Consulting Services, specializing in Quality Systems and Regulatory Affairs for medical device companies. Mr. Besseling has over 35 years experience in the medical device industry, as design manager and regulatory specialist. He implements quality systems, using standard operating procedures (SOP’s) that he has developed over years of working with small and medium sized companies. He also specializes in risk management and design control.

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