EUDAMED Go-Live is March 2020: Why waiting for more Technical Specifications is NOT a winning strategy
EUDAMED deadlines remain unchanged – the go-live date is still March 26, 2020 with the Date of Application for device registration/submission standing at May 26, 2020. Yet, we’re nearing the end of 2019 with most med device companies still struggling to fully...
Healthcare Insights: PIM vs PLM – What’s the Best Method to Address Regulatory Data Submission Challenges?
There’s a mounting list of regulations aimed towards Unique Device Identification (UDI), intended to improve patient safety, supply chain efficiency and post-market surveillance. The benefits are numerous, but challenges continue for medical device suppliers on their...
Success Spotlight: Global Medical Device Supplier
The goal of UDI is to help improve patient safety by enabling better traceability of medical devices consumed. For the ‘labeler’, UDI will help improve internal processes, bolster master data quality, and provide more accurate reporting and visibility related to...