Day 1 – Wednesday, Oct. 7, 2020
Welcome and Introduction by Chairperson
King & Spalding LLP
former FDA Deputy Associate Commissioner for Regulatory Operations
FDA’s 2021 Medical Device Regulation Agenda: CDRH’s Priorities
King & Spalding LLP
former FDA Deputy Associate Commissioner for Regulatory Operations
Are you addressing CDRH’s top strategic priorities for FY 2021 head on? If not, your devices might be left behind.
This session will enable you to get ahead of your competition:
- Operating and maintaining quality during a pandemic
- CDRH reorganization — what it means for your devices and processes
- Comparing QSR v. ISO13485:2016
- Get ready for the planned software validation guidance documents
- How to address moving to a risk-based inspections approach — and what inputs will influence your results
- MDSAP program — what it means for your devices
- The truth about FDA’s new shipment examination program at ports of entry
Implementing the Clinical Evaluation or Performance Evaluation Process
Regulatory & Quality Solutions (R&Q)
Do you know the ins and outs of the clinical evaluation system (EU-MDR) and performance evaluation system (EU-IVDR) requirements?
Also, if you’re looking to obtain a CE Mark, this presentation is a must.
Gain the tools you need to ensure success:
- EU-MDR’s and EU-IVDR’s significant differences from the regulations
- Secrets of the new requirements for clinical and performance evaluation
- How to prepare your documents to meet the notified body’s (NB’s) requirements
- Using the NB’s review process to your advantage
- The best way to respond to issues raised by the NB
- When it benefits you not to perform a clinical evaluation or performance evaluation — and how to document it and present it
Break
Panel Discussion: EU-MDR and IVDR QMS
EU-MDR and IVDR Consulting Services
Regulatory & Quality Solutions (R&Q)
Ombu Enterprises LLC
NSF Health Sciences
Former Medical Device Specialist and Senior Investigator
ORA and International Team Lead
CDRH, FDA
Is your quality management system (QMS) foolproof? While the new EU regulations require a QMS with significant extensions from ISO 13485:2016, chances are it only partially covers the regulation’s requirements. In some cases, ISO 13485:2016 might not cover any of the requirements. Where does your QMS fall? Are you compliant?
Session attendees will discover:
- Takeaways of the tools, methods and checklists you must have to implement an effective and compliant QMS
- The areas where ISO 13486:2016 does not meet the requirements of the regulations — and how to close the gaps using CEN/TR 17223:2018
Break
Impact of New Economic Operators on You, the Manufacturer
Ombu Enterprises LLC
The EU-MDR has six types of economic operators and the EU-IVDR has four — each with specific and well-defined requirements in their relationship with you, the U.S. device manufacturer. Understanding the specialized roles of each economic operator is vital, while ensuring economic operators’ accountability is key to compliance — and key to business success in the EU.
Gain new insights on enforcing economic operators’ accountability to stay compliant:
- Understand the specific role each economic operator plays in bringing a device into the EU and getting it to customers
- The interconnections among economic operators (verifying activities, information exchange, product liability requirements and insurance obligations)
- How best to map the distribution channels
- Get a handle on the supplier management requirements and contractual obligations
- Essential contract elements between you and each economic operator
- Economic operators’ obligations to the competent authorities