The two new final guidances are intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and post-approval study requirements.
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).
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Timely compliance will ensure that your products will not be considered misbranded.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
The hot issues are related to compliance, EU MDR and recalls.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.