New FDA Guidance for CM&S in Medical Device Submissions

by PRP Consulting Team on Nov 27, 2023 6:47:02 PM

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

New FDA Guidance on the Q-Submission Process

by PRP Consulting Team on Nov 5, 2023 3:03:50 PM

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...

5 Ways to Maximize your Quality Management System

by PRP Consulting Team on Oct 16, 2023 2:09:09 PM

With the release of the latest ISO 13485 version in March of 2016, Quality Management Systems (QMS) became a primary focus within the medical device...

Quality Challenges in Automotive - 5 Things You Need to Know

by PRP Consulting Team on Sep 28, 2023 12:48:18 PM

The automotive industry has certainly had its share of challenges over the past three years. The COVID-19 pandemic, supply chain issues including...

Authorized Reps under EU MDR

by PRP Consulting Team on Sep 5, 2023 2:57:00 PM

The introduction of EU 2017/745 (“EU MDR”) has brought about significant changes within the medical device industry. The fundamental landscape of our...

Important Updates - EUDAMED

by PRP Consulting Team on Jul 26, 2023 4:18:06 PM

In June 2023, the European Commission (“EC”) released its comprehensive user guide for EUDAMED for UDI Devices. EUDAMED is the IT tracking system...

Important FDA Updates - Software as a Medical Device "SaMD"

by PRP Consulting Team on Jun 29, 2023 7:40:18 PM

On June 14, 2023, the FDA published the final version of its software guidance titled “Content of Premarket Submissions for Device Software...