Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

EC Rep To EU Rep: The Symbol Shift You Can't Ignore

The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling from the legacy “EC REP” symbol to a more flexible, jurisdiction-specific format: “XX-REP.”

How AI Is A Game-Changer For Auditing Compliance And Efficiency

In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

WHITE PAPERS & CASE STUDIES

Ophthalmic Delivery Systems: Drug And Device Testing For Regulatory And Patient Compliance

Explore ophthalmic drug and device testing, focusing on regulatory and patient compliance, including design considerations, testing methodologies, safety, and efficacy for medical device development.

Meeting Annex 1: A Proactive Approach To Regulatory Compliance

It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

Sustainable Solutions For Medical Devices

Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

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.

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