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.

Artificial intelligence and machine learning (AI/ML) represents an entirely new paradigm for medical device regulations.

The new European Union Medical Device Regulation ("EU MDR") represents one of the most significant and impactful regulations within the medical device industry in decades. The new regulation brings about substantial changes for both medical device companies and Notified Bodies, in an effort to enhance transparency and patient safety.

One of the most prominent regulations within the medical device industry is ISO 13485, which specifies requirements for a quality management system to ensure compliance with appropriate standards.

Since the 1990’s, there had been very few updates to European regulations in the medical device industry.

At PRP, we understand the challenges faced by Quality & Regulatory Compliance teams in the pharmaceutical and medical device industries.

GDPR, or the General Data Protection Regulation, has become a critical priority for Pharmaceutical and Medical Device companies as the mandatory deadline for compliance of May 25, 2018 is upon us.

The Medical Device Single Audit Program (MDSAP) allows for medical device manufacturers to undergo a single regulatory audit that covers the requirements of several jurisdictions.

Are you a supplier to pharmaceutical and medical device companies? If so, you should be taking a hard look at your own supplier diversity initiatives. Supplier diversity programs are becoming extremely prevalent in the pharmaceutical and medical device industries.

Regulatory Compliance and Quality professionals in the Life Sciences industry face constant challenges on a daily basis.

The need to supplement your employees with external resources is very common in the pharmaceutical and medical device industries, particularly within the Quality and Regulatory Compliance space.