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...
Is PTC Windchill Exiting the UDI Compliance Market?
If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation. Recent announcements suggest that PTC is...
Success Spotlight: GPC Asia Pacific (Repco)
Today’s Success Spotlight With over 13,000,000 vehicle parts relationships, GPC Asia Pacific (Repco), a leading provider of automotive aftermarket parts and accessories, manages a catalog of over 1,300,000 items with approximately 50,000 vehicle makes/models. Using...
