11:00 am – 11:05 am Welcome and Introduction
Maria Fontanazza – Editor-in-Chief, MedTech Intelligence.Com
11:05 am – 11:30 am Implementation Overview
Dr. Basssil Akra, Vice President, Strategic Business Development, Global Medical Health Services, TÜV SÜD
- Can we make it in time?
- Do we have enough Notified Bodies? Will we get an extension?
- How should we manage scheduling our TD reviews to MDR will our NB aned scheduling our MDR audits (especially for small/medium size manafucturers?)
11:30 am – 12:00 pm Strategies for addressing the unknowns around what product changes can be made in the soft transition?
Keith Morel, Ph.D., VP Regulatory Compliance, QServe Group
- Strategies on how to deal with ambiguity of what changes can be made in soft transition
12:00 pm – 12:30 pm Clinical Data Evaluation under MDR
Carolyn McCuan, Consultant, QServe Group US, Inc.
- Practical experience from writing CEP/CERs to meet MDR
- Common pitfall/mistakes/gaps we see
- Scoping is poor; no CEP; Lit. search requirements not met; clinical outcomes not clear/not defined; don't have data to support all claims; PMS/PMCF insuffient; equivalence argument not convincing
- How to address those (techniques/examples used)
- Other lessons learned/important points you've picked up in your practise in this past year or so as we prepare for MDR.
12:30 pm - 12:45 pm HealthLink Europe Technology Spotlight
Kay Bonavita, VP, Sales, HealthLink Europe & International
12:45 pm – 1:15 pm PMS
Carol Romero, Associate Manager, Quality Programs, Stryker Neuro
- PSUR creation
- Timing/content (including usage, patient population)
- Getting the information needed
- Defining roles and responsibilities between departments/functions
- Analyzing the data and drawing conclusions, holistically, across various data sources
- Connecting with other plans and reports in the QMS
- Timing and connecting with CER (per class)
1:15 pm – 1:45 pm Automating the various plans-reports needed under MDR - Managing the content tsunami
Marc Miller, Division President,TransPerfect Medical Device Solutions
- Automating the PMS-PMCF-CEP-CER-SSCP plans and report content creation
1:45 pm – 2:10 pm EU MDR, UDI, Labeling - Regulatory Requirements
Mark Cusworth, VP, Research & Development, PRISYM ID
- EU MDR label requirements compared with MDD and AIMDD
- Label - before and after EU MDR
- Comparison of EU MDR & FDA UDI
- EU MDT Labeling solutions
2:10 pm - 2:35 pm Economic Operators
Nic Pugliano, Regulatory Affairs - Medical Products, W. L. Gore & Associates, Inc.
- How can large manufacturer handle the various verifications that the manufacturer, importer and distributor need to perform and avoid duplication?
- Should Economic Operators be maager through the Supplier Management process within the QMS (ISO 13485:2916 clause 7.4?
2:35 pm - 3:00 pm Eudamed
Richard Houlihan, CEO, Eudamed Ltd.
3:00 pm – 3:15 pm Questions and Answers