All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in foc [...]
Supplier Quality Management: A New QMS-Based Approach
According to research firm LNS Research, fewer than 1 in 5 companies have a robu [...]
Elements of an Effective Supplier Scorecard
Imagine if your plant is starting work on a big order. You’ve just been advised [...]
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, [...]
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the [...]
Remote Audits in the Age of COVID-19
Amid the ongoing pandemic, groups like the European Commission (EC) and the Inte [...]
Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software
AssurX Platform Automates Document Management and Training Management; More Proc [...]
EU MDR Countdown: What’s Next for Medical Device Compliance
In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]
Addressing the EU MDR and IVDR Certification Bottleneck
With the May 26, 2021 implementation deadline looming for the new EU Medical Dev [...]
EU MDR Compliance Check-in: Challenges and Action Items
The new EU Medical Device Regulation (MDR) goes into effect in less than six mon [...]
