EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
25
08, 2022
20
07, 2022
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats a [...]
30
06, 2022
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
26
05, 2022
EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]
20
04, 2022
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
31
03, 2022
miraDry Implements AssurX Quality Management and Regulatory Compliance Software
MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]
31
03, 2022
How an EQMS can Reduce CAPA and Complaint Observation Trends
As we move through 2022, we look forward to new opportunities, new challenges, a [...]
24
03, 2022
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
This article is part two of a two-part series focused on GMP quality audit manag [...]
17
03, 2022
Remote Quality Audits for Regulated Companies Come of Age
This article is part one of a two-part series focused on GMP quality audit manag [...]
3
03, 2022
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]
