ComplianceOnline

Medical Device Software Risk Analysis

Instructor: Edwin L Bills
Product ID: 700902
  • Duration: 60 Min

recorded version

$249.00
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

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: +1-650-963-2556

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This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis.

Description

This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.

Software which is a component of medical devices, software that is a medical device, and software used as part of the production of medical devices and the quality systems require risk management. This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis.

Areas Covered in the seminar:

  • Identifying software defects and software functions that could result in hazardous situations leading to harm.
  • Determining Intended Use for the risk analysis process.
  • Identifying known and foreseeable hazards.
  • Identifying the cause of software hazards.
  • Estimating the risk of software hazards.

Who will benefit:

This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems. The employees who will benefit include:

  • Design personnel using risk management during development of new medical device software
  • Quality managers responsible for overseeing risk management for quality system software
  • Regulatory and compliance personnel who develop premarket filings and technical files for medical devices
  • Personnel responsible for software validation activities
  • Quality system auditors

Instructor Profile:

Edwin 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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