MDR and Class I Medical Devices – What’s In, What’s Out?
European Commission announced last October that the new EUDAMED will not launch until May 2022, giving everyone enough time to properly prepare for implementing M2M data exchange with EUDAMED. Further, a grace period was also introduced by the EU for certain classes...
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Is GHX Discontinuing Support for GUDID and EUDAMED?
In September 2019, we witnessed PLM software giant, PTC Windchill, quietly exit the UDI compliance market. As we ended 2019, several little birds have shared that GHX is slated to phase out support for their GUDID Connector and will not be providing a EUDAMED...
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Healthcare Insights – 2019 Recap
Happy New Year! As the dust settles from the holiday madness and end-of-year celebrations, we thought we’d take a quick look back and reflect upon our 2019 journey. We’re so fortunate to work with an amazing roster of customers and partners whose relationships are...
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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...
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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...
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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...
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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...
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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 catalogue of over 1,300,000 items with approximately 50,000 vehicle makes/models. Using...
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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...
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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 ‘labeller’, UDI will help improve internal processes, bolster master data quality, and provide more accurate reporting and visibility related to...
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