EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
Inspecting for quality after a process is completed is reactive and outdated. Instead, the future lies in predicting quality and quality issues. For medical device manufacturers, the advantages in predictive quality are so great they simply cannot be ignored.
The only constant today is change itself.
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform
As more guidance is released, we can expect to see more agreement between competent authorities and notified bodies. Until this happens, there are still actions you can take to help eliminate the uncertainty.
The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look.
In this segment of Ask the Experts, James Thompson of Siemens responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.
A discussion with Peter Willemse about how configure, price, quote (CPQ) software can help medical device manufacturers deal with the nuances of everyday challenges and continue to drive revenue and increase profit margins.
A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit.