In this informal session, our resident medical device guru Griffin Jones, in collaboration with Jaimie Cole of iCardiac, share their expertise and unique insight on medical device certification and how it applies to your company.
Speakers
Griffin Jones
Consultant at Congruent Compliance LLC
Jaimie Cole
Vice President of Technology, iCardiac
Regg Struyk
Product Manager Polarion QA
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 integrating requirements with software in a regulated environment, particularly in accordance with IEC 62304.
This webinar is right for you, if you want to:
- Achieve IEC 62304 compliance quicker
- Create audit-related reports faster to meet auditors requirements
- Prove and track implemented processes, actions, and approvals at a forensic level during the entire lifecycle
- Collect and mitigate all upcoming risks properly
- Base reports on all relevant information and publish auditor-ready-style
“Polarion is helping us achieve the higher quality that we aspire to reach, saving money at the same time.”
— Jim Mapel, Cyberonics