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...
What you need to know about Software as a Medical Device "SaMD"
by
PRP Consulting Team on Jun 2, 2023 4:45:58 PM
In recent years, software has become an increasingly prevalent factor in multiple industries, and the medical device community is no exception. The...
