Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
2
11, 2022
12
10, 2022
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
5
10, 2022
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]
1
09, 2022
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assess [...]
25
08, 2022
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
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FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System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 [...]
