The MDM West 2020 in Anaheim, USA, took place a few weeks ago and it was a very interesting and informative fair. The companies present are critical links in the medical device supply chain and offer a wide range of specialty products and components. When I think about medical devices and our familiar consumer products, which we all need and purchase every day, there are some remarkable comparisons that I would like to highlight.
Key device data is very similar to consumer product data because it is shared and used by commercial organizations such as hospitals and Group Purchasing Organizations (GPOs) for purchasing decisions. This makes the quality and integrity of the data exchanged between partners and regulators critical. Data exchange solutions can achieve a certain level of certification to ensure the integrity of medical device data. ISO certifications such as ISO27001 let manufacturers know that companies like atrify treat information about devices with the same rigor as the industry does with the devices themselves.
This is important because, as mentioned above, this data needs to be shared both between trading partners and between regulators. Important at MDM West was the topic of achieving the required regulatory compliance such as GUDID and EUDAMED. EUDAMED in particular was of interest to many of the manufacturers I spoke to during the week. EUDAMED compliance is more complex than FDA GUDID and requires more system testing and certification to share information.
The ability to collect, validate and syndicate medical device information in an efficient and secure way is as important as the ability to move the actual devices throughout the supply chain. atrify’s secure (ISO27001) and direct access to regulatory databases like EUDAMED, FDA GUDID, and the upcoming UDI databases, as well as numerous commercial endpoints such as Hospitals and GPOs, make atrify the best choice (for achieving economies of scale in addressing 1 or more of these requirements from a central data source, via 1 service provider.)
Our video from MDM West (see above) covers these and other important aspects of data exchange and UDI compliance for medical devices.
