ComplianceOnline

Overall Residual Risk and Risk Acceptability for Medical Devices

Instructor: Edwin L Bills
Product ID: 700622
  • Duration: 60 Min

recorded version

$299.00
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: Oct-2007

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Residual Risk and Risk Acceptability webinar/training in medical devices will discuss how to meet this requirement and also how to determine what disclosures of risk need to be made in the instructions for use of the medical device and Proper evaluation of overall residual risk and the acceptability of this risk.

Why Should You Attend:

One of the requirements for Risk Management in Medical Devices is after product developers have reduced all individual risks associated with a medical device as far as is reasonably possible, they must establish an overall residual or remaining risk level. This level of overall residual risk must reflect the cumulative effects of the individual risks. This presentation will discuss how to meet this requirement and also how to determine what disclosures of risk need to be made in the instructions for use of the medical device.

Areas Covered in the seminar:

  • What is Overall Residual Risk?
  • How does Overall Residual Risk relate to Residual Risk for each hazard?
  • Some companies use a risk rating of ALARP, how does this rating relate to Overall Residual Risk?
  • How is Overall Residual Risk reviewed for risk acceptability?
  • What information about Overall Residual Risk needs to be disclosed to users? To others?
  • How is Overall Residual Risk disclosed?

Who Will Benefit:

This webinar will provide necessary information to medical device companies on the proper evaluation of overall residual risk and the acceptability of this risk. Also the disclosure of overall residual risk information will be a focus of this presentation.

  • Teams responsible for evaluation of designs to determine acceptability of the product prior to release
  • Regulatory personnel responsible for approval of product literature and also approval of product for release
  • Design personnel responsible for the risk management of medical devices
  • Quality personnel responsible for risk management activities
  • Quality system auditors

Instructor Profile:

Edwin L Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.

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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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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