Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

How Is RIM Software Transforming Regulatory Compliance?

Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

Key Regulatory Landscapes For SaMD Around The World

As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are evolving to keep pace.

A Look At Elsa, The FDA's New AI Digital Assistant

The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

WHITE PAPERS & CASE STUDIES

The 5 Ws Of A Human Factors Strategy

A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

Selecting The Best Deterministic Method For Your CCIT Project

Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

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%.

LATEST HEADLINES