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...
Eudamed: Technical Specifications Update
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 members of MedTech Europe and Healthcare Transformation Group, we’re doing...
Key Takeaways from GS1 Connect 2019 – Dynamic Innovation & Outstanding Leadership
Last month, over 1,200 guests traveled to Denver, Colorado for GS1 Connect 2019, the annual 3‑day conference bringing IT and supply chain partners together to learn best practices for leveraging GS1 Standards that drive innovation and better understand new...
Point of Care Scanning at Hospitals – Why Trusted Data is Key
Healthcare providers are increasingly putting emphasis on a patient-centric approach to care delivery. From ensuring patient safety to providing quality care at an affordable cost, care providers have embraced healthcare information technologies as a cornerstone to...
We’re Here – GS1 Connect 2019!
Join Innovit June 19-21 in Denver, CO The GS1 Connect 2019 conference in Denver, CO kicks off THIS WEEK and we're ready for three days of thought-provoking sessions, collaboration and networking opportunities. It’s a great event – and a perfect opportunity for us to...
FDA’s GUDID Medical Device Data Corrections – Implications of the Shortened Grace Period
In 2014, the seven-day grace period for Global Unique Device Identification Database (GUDID) submission corrections was extended to 30 days. Over time, healthcare providers provided feedback stating that 30 days is too long to wait for access to "key information"...
Key Takeaways from the Europe Commission’s New EUDAMED Data Exchange Guidelines
As it prepares to meet new regulatory requirements in Europe, the medical device community is following developments regarding the European Database for Medical Devices (Eudamed). Most recently, the European Commission (EC) released three documents for Medical Device...
The Latest UDI News: Convenience Kits Q&A from the FDA
Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...