The development of safety-critical medical devices presents special challenges at every step, from product conceptualization through design, development and testing, to regulatory approval and post-market oversight and support.
Polarion’s interactive webinar will help regulatory, quality and R&D professionals understand the special issues of product development and how they relate to risk management in a regulated environment, including EN ISO-14971.
This Webinar is right for you, if you want to:
Manage important Document content – Requirements, Design, Testing, and More
Integrate key Risk Management concepts of Harms and Hazards, dFMEA and pFMEA, and Production Readiness
Define and maintain instantaneous traceability between Design, Process requirements and Hazards
View crucial Reports on-demand, and real-time
Enforce and Prove compliance with ISO-14971
Please register to get immediate access to this on-demand webinar.