On-demand Webinar:

Mitigating and Managing Risk for Medical Device Product Development



Laurence Sampson
President of SampsonSurgical



David Merrill
Polarion Software

Who should watch this webinar?

Executive Management, Regulatory Managers, Product Design/Development Managers & Engineers, Product Managers, Project Managers, Quality Control/Assurance – anyone involved with safety-critical medical device development.

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.