PMCF Process in Action: Best Practices for MDR Compliance
--- DEVICE L❤️VE Live! is a weekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device industry. Please view our blog for a other shows, along with other R&Q events and learning opportunities. ---
Recently we discussed the increased scrutiny in initial MDR certification reviews and even routine MDD audits. Building on that, in this Live! session we’ll go into details of Post-Market Clinical Follow-Up Activities. Our focus will be on PMCF questions we are seeing during notified body review and best practices to help you avoid having these questions raised in the first place! We’ll describe best practices for developing a clinical evaluation matrix and our interpretation of the MDCG 2020-6 guidance on sufficient clinical evidence for legacy devices, then using it to drive an overall PMCF Strategy and execution of PMCF Plans and Reports using MDCG 2020-7 and MDCG 2020-8.
The panel will include:
- Ibim Tariah, Ph.D. — R&Q VP of EU MDR/IVDR Consulting Services,
- Jon Gimbel, Ph.D. — R&Q Exec. Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER business
- Johnna Dominick — Project Controller
- Celeste Maksim, Ph.D., RAC — Principal Specialist