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...
PRP Consulting Team
Recent Posts
5 Ways to Maximize your Quality Management System
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
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
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
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"
On June 14, 2023, the FDA published the final version of its software guidance titled “Content of Premarket Submissions for Device Software...
What you need to know about Software as a Medical Device "SaMD"
In recent years, software has become an increasingly prevalent factor in multiple industries, and the medical device community is no exception. The...