All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focu [...]
5
05, 2021
20
04, 2021
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramat [...]
22
03, 2021
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, [...]
8
03, 2021
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the [...]
3
02, 2021
Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software
AssurX Platform Automates Document Management and Training Management; More Proc [...]
14
09, 2020
AssurX Focuses on Medical Device Compliance at RAPS Convergence 2020
AssurX is participating in the first virtual RAPS Convergence Conference current [...]
4
08, 2020
Why Consider a Cloud QMS for FRACAS Automation?
Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Sp [...]
28
07, 2020
Prioritize QMS Process Automation or Risk Failure
This blog is part of a three-part series on proven strategies to help avoid QMS [...]
13
07, 2020
A Successful QMS Implementation Requires Clearly Defined Processes
This blog is the second of a three-part series on QMS implementation best practi [...]
13
07, 2020
Avoid QMS Implementation Failures with the Right Team
This blog it the first of a three-part series on QMS implementation best practic [...]
