Risk Management as applied to Design Control

Instructor: Nicolaas Besseling
Product ID: 701212
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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