UDI & MDR Resources for Medical Device Makers

Key differences in the requirements for SFDA UDI and US & EU UDI

Blog article topic: Key differences in the requirements for SFDA UDI and US & EU UDI.

Jay Crowley
- January 29, 2022

Blogs

Medical Device

Manufacturing, Regulatory

Q&A: UDI Registration in EUDAMED

Blog article written from the Q&A during the UDI Registration in EUDAMED webinar.

Jay Crowley
- January 29, 2022

Blogs

Medical Device

Regulatory, Safety

Medical Device Company Updates 450 QMS SOPs in time for EU MDR

Case study on Medical Device Company Updates 450 QMS SOPs in time for EU MDR.

Jim Macdonell
- January 21, 2022

Case Studies

Medical Device

Regulatory, Safety

EU MDR Date of Application Readiness Guide

Learn how to navigate EU MDR compliance for medical devices. Understand key deadlines, classification rules, vigilance, and post-market surveillance. Download now!

Jay Crowley
- January 17, 2022

White Papers

Medical Device

Clinical, Manufacturing, Quality Assurance, Regulatory, Research & Development, Safety

Cloud Content Management with Automated GxP Compliance Built In

Download this white paper and learn how you can securely share data with partners, vendors, and regulators while complying with GxP requirements globally.