Today, medical device manufacturers are facing a wide array of data compliance demands from healthcare providers, and national regulators including the European Commission, FDA and China’s NMPA. With the introduction of GUDID and now EUDAMED, these repositories capture important regulatory and clinical information about medical devices. Of course, the primary goal of these various regulations is to help improve patient safety, and public health at large.
For suppliers, UDI and MDR compliance will improve internal processes, bolster master data quality, and provide more accurate reporting and visibility to help with product recalls and minimise counterfeit devices.
Unfortunately, manual submission methods via data entry or Excel spreadsheet uploads to the regulator’s UDI portal are time‑consuming and error-prone. A cloud-based UDI compliance system will help your organisation achieve data compliance with local market requirements, ensure data validation, track submission activities, enhance data quality while reducing operational and IT costs.
Having a system that includes an extensive repository of highly relevant domain knowledge & experience on UDI compliance, which explains the nuances across different markets around the globe, will help your Regulatory Affairs, Quality Assurance and Master Data stewards navigate the varying and complex requirements of medical device regulations.
However, it’s an ever-changing landscape, and the entire process can present a myriad of challenges as companies move forward. Not to mention the ongoing delays and frequent deadline postponements – all of which can cause continued confusion and frustration. Of course, it’s safe to anticipate that more regulatory changes are likely. Therefore, medical device companies understand that they must act now to automate their process for product data submissions to comply with local market regulations.
As a global software solution vendor in Life Sciences & Healthcare, Innovit customers include many of the top medical device suppliers that manage tens of thousands of device records. So, their businesses want and need to ensure ongoing data compliance. That’s why we have made it a priority to proactively partner, consult and collaborate with key regulatory agencies and industry associations such as EU Commission, MedTech Europe, EUDAMED Leadership Council, Healthcare Transformation Group and more.
Here are three other ways that Innovit is leading the charge in healthcare regulatory compliance.
‘EUDAMED Playground Testing’
We attend meetings, provide commentary, participate in EUDAMED testing and offer our professional insights and recommendations. This level of collaboration gives us the opportunity to provide technical feedback to help refine system designs as well as uncover problems or potential issues. Innovit continues to lead the charge for M2M testing working alongside other MedTech Europe members and provides a unique platform to deliver an automated data submission solution for EUDAMED through our hands-on experience in the early rounds of testing. Innovit has the broadest coverage for both MDR and IVDR testing.
‘Complete Solution Offering’
We are the only solution provider with both a direct connector for the FDA’s GUDID and a GDSN-based solution for UDI submissions. We are also the only solution provider for EUDAMED that is offering both structured master data submissions and unstructured data submissions (Vigilance and post-market surveillance forms and reports) – providing a ‘complete’ EUDAMED compliance solution for medical device data submissions.
Present-day regulatory compliance strategies need to be executed with a future-oriented mindset. It’s the only way to succeed now, while purposefully setting up your company for continued success down the road. We also believe that early adopters a rewarded with “first-mover advantages” especially in relation to the competition. Unfortunately, many organisations struggle to find the knowledge and expertise to execute effectively. But don’t worry – we’ve got you covered.
EUDAMED Compliance: Meeting the Deadline
The EUDAMED compliance deadline of 2022 is fast approaching, and immediate action is critical. To begin machine-to-machine testing, your product data must be cleansed and validated. Submitting data manually when you have thousands of product records is treading a dangerous path. Ready to learn more? Schedule a consultation today!