EUDAMED – Deadlines Updated
The European Commission recently announced that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020. Given this postponement, we now have the opportunity, and sufficient time, to properly prepare for implementing M2M data...
The Demerger of 1WorldSync & Atrify: How it Impacts FDA GUDID Users
The beginning of July brought several major announcements in the product content and data synchronization market. The joint venture between GS1 Germany and GS1 US effectively ended with the demerger from 1WorldSync, which has evolved as follows: Battery Ventures, a...
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...
Healthcare Innovation in 2040: The Next Big Thing in Patient Care
We pride ourselves on being experts in MDM and PIM. But we also pride ourselves in keeping up with new technologies and industry trends. Today, we're taking a long view - after all, why look to 2020 when we can leapfrog to 2040 to reveal a potentially different...
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...
What is the best path for UDI compliance? Examining Two Approaches for Medical Device Suppliers
As a global software solution vendor in Life Sciences & Healthcare, our customers include many of the top medical device suppliers managing high volumes of product data and tens of thousands of device records. Based upon our experience helping customers with FDA’s...
Healthcare Insights: Medical Device Regulation Updates – What You Need to Know
Keeping up with the evolving medical device regulation and compliance landscape can be challenging, particularly when technical specifications from the EU Commission are repeatedly delayed. As a global software solution vendor for Life Sciences and Healthcare...