4 min read
Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual...
Manufacturing Solutions
2 min read
Avoid These Four Medical Device Supply Chain Woes
Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and...
4 min read
Built to Fit Your Needs: Our CDMO Capabilities
Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
2 min read
New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to...