As 2020 approaches, there are many worthwhile conversations to be had about the remediation and implementation challenges posed by the regulations.
SANTA BARBARA, Calif. (PRWEB) April 19, 2018
USDM Life Sciences, the leading risk management, technology innovation and business process optimization firm for the life sciences and healthcare industries, announces a live workshop on the EU Medical Device Regulation (MDR) with Jay Crowley and Wellington Merritt.
- What: Live Workshop - The New EU Medical Device Regulation (MDR): A Project Implementation Approach
- When: Thursday, April 26, 2018, 11am PT / 2pm ET / 6pm GMT
- Who: Jay Crowley, VP of UDI Services and Solutions and Wellington Merritt, MDR R&D Program Manager at USDM Life Sciences
- Where: Register Here
“I’m looking forward to this workshop, where we will discuss the new EU MDR regulations from a program implementation standpoint,” said Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences. “As 2020 approaches, there are many worthwhile conversations to be had about the remediation and implementation challenges posed by the regulations.”
The new EU Medical Device Regulation (MDR) entered into force on 25 May 2017, which means the transition period from the Directives has already started. The new regulation’s date of application is 26 May 2020. The deadline is approaching. Have you planned your required remediation and implementation activities? Will you be compliant? Will you continue to distribute devices in the EU?
The discussion will include:
- The compliance dates - especially the requirements due by 26 May 2020
- Strategies for addressing and complying with this complex regulation
- Requirements for “legacy” devices with a valid MDD/AIMD certificate
- Requirements for class I, “new,” and devices with expiring certificates
- Live Q & A session
Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. He was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.
Wellington Merritt is an MDR R&D Program Manager at USDM Life Sciences. His expertise includes UDI & MDR Integration Strategy, Data Services, Visual Management, and Continuous Improvement.
Register for the workshop here.
About USDM Life Sciences:
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world and boast a staff of industry leading experts in the areas of technology and compliance. USDM Life Sciences is doing business as USDM Europe GmbH in Germany.