On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

The market opportunity lies in providing solutions and services for global medical device companies to comply with US FDA and EU MDR post-market surveillance and complaint handling requirements. This ...

In February 2026, the medical device industry will be faced with new regulatory challenges that could shake up operations. The good news? Companies that are already in compliance with existing FDA ...

DUBLIN--(BUSINESS WIRE)--The "Efficient Batch Record Design and Review" training has been added to ResearchAndMarkets.com's offering. This online training is designed for professionals in the ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 ...

The "An introduction to Risk Management ISO 14971:2019 Training Course (Apr 27, 2026)" has been added to ResearchAndMarkets.com's offering. Understand the use of risk management in the medical device ...

In the unforgiving landscape of medical device development, where regulatory deadlines intersect with clinical imperatives ...

Join our team of experts as we explore the extensive capabilities of D365 with Alithya 365 Enhanced Quality and Compliance, providing your medical device organization with the tools and insights ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

Hospitals and integrated delivery networks rely on a wide range of medical devices to deliver safe and effective clinical care. The good news is that suppliers are continually launching new, ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...