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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
EQMS Implementation: How to Lead Organizational Change
The Kübler-Ross Change Curve®, adapted from the original five stages of grief (originally published in 1969), has been e [...]
Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software
AssurX Platform Automates Document Management and Training Management; More Processes Planned MORGAN HILL, CA, UNITED ST [...]
EU MDR Countdown: What’s Next for Medical Device Compliance
In four months, the new EU Medical Device Regulation (MDR) goes into effect, which officially means it’s crunch time for [...]
Addressing the EU MDR and IVDR Certification Bottleneck
With the May 26, 2021 implementation deadline looming for the new EU Medical Device Regulation (MDR), medical device com [...]
EU MDR Compliance Check-in: Challenges and Action Items
The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical dev [...]
How to Meet New EU MDR Requirements for Vigilance and Reporting
After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is [...]
