DUBLIN--(BUSINESS WIRE)--The "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" conference has been added to ResearchAndMarkets.com's offering.
This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. The course will additionally address the software risk management and the resulting interfaces to device level risk management.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.
- Lecture 1: Introduction into Risk Management and Quality System Integration
Lecture 2: Risk Management to ISO 14971:2012
- Lecture 1: Usability and Risk Management
Lecture 2: Software Risk Management (IEC62304 / FDA software
reviewers' guidance) P1
Lecture 3: Software Risk Management (IEC62304 / FDA software
reviewers' guidance) P2
- Lecture 4: Safety / Assurance case
System Safety Inc.
For more information about this conference visit https://www.researchandmarkets.com/research/q87lxz/2_day_seminar?w=4