The growth of wearables and smart, connected devices is ushering in a new era of patient-centric care. With 3-D printing, personalized medical device technology is now a reality. The convergence of the physical and digital worlds is here, now.
This new complexity also introduces new threats to profitability and increases the risk of recalls. It also underscores the ever growing need to address requirements of the FDA, EU MDR, and other regulatory bodies. Stay up to date on latest articles, reports, and blogs.
The European Union Medical Device Regulation (EU MDR) is the most significant revision to the EU regulatory system in over 20 years. If you’re like most medical innovators – still searching for a workable solution – PTC can help.
This guide covers all the essential details you need to understand the data requirements of EU MDR product submissions and how to comply.
This independent guide identifies the critical challenges, key capabilities, and vendor selection criteria needed to choose the right medical device technology.
A product-centric approach makes it possible to easily propagate changes across the entire lifecycle, from design to manufacturing.
According to Aberdeen, using a combination of PLM and Quality Management systems can lower internal and external failures by 50%.