Medical Device Software Risk Analysis
Instructor:
Edwin L Bills
Product ID: 700902
- Duration: 60 Min
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
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.
More Training By Experts
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
