For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and market access.

The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) was released back in 2017 and represents one of the most impactful regulations ever within the medical device industry.

Artificial intelligence (AI) is revolutionizing industries worldwide, and the life sciences sector is no exception.

Cannabis and cannabis-derived products (CDPs) have become increasingly prevalent throughout the medical community.

Earlier this month, the FDA published a Discussion Paper titled “Health Equity for Medical Devices”.

On August 22, 2024, the FDA issued a new draft guidance document titled “Predetermined Change Control Plans for Medical Devices”.

The medical device landscape is rapidly evolving, with advances in technology and shifts in patient needs creating new opportunities for innovation.

On August 6, 2024, the Audit Approach document under the Medical Device Single Audit Program (“MDSAP”) was updated to Version 009.

In August 2024, the FDA announced the release of final guidance titled “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.”

The distinction between “servicing” and “remanufacturing” has often caused confusion throughout the medical device industry.

The impact of Artificial Intelligence (“AI”) is being seen throughout society, and the medical device community is no exception.

The FDA recently announced its planned enhancements to the Electronic Medical Device Reporting (eMDR) System.

Following years of discussion and debate, the FDA officially published its final rule covering laboratory developed tests (“LDTs”) on May 6, 2024.

On March 13, 2024, the European Parliament approved the Artificial Intelligence Act (“AIA”), which represents the first comprehensive legal framework regulating artificial intelligence (“AI”) in the European Union.

A growing trend in the medical device industry has been the ongoing efforts by FDA to harmonize with international standards.

On April 25, 2024, the European Commission issued a press release announcing that additional time will be granted to companies to transition to the new requirements under the In Vitro Diagnostic Medical Device Regulation (IVD Regulation).

On January 31, 2024, the FDA issued its highly-anticipated Quality Management System Regulation (“QMSR”) Final Rule which amends current good manufacturing practices (CGMP) for devices under 21 CFR Part 820.

Discover the essential steps for medical device manufacturers to ensure FDA regulatory compliance and quality standards.

On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”.

The introduction of new and complex regulations, combined with the need to get safe and effective devices approved and into the market as quickly and efficiently as possible, has created quite a challenging environment in today’s medical device industry.