Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?

9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.

The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025

Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.

Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions

In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.

WHITE PAPERS & CASE STUDIES

Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs

Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. Discover how they can minimize complexities and better align with the stringent demands of modern pharmaceutical manufacturing.

Solving The Silicone Challenge In Pre-Fillable Syringes

Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

Performance Test According To Chapter <41> Of The USP

This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the United States Pharmacopeia.

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