AssurX Blog
Straight talk for regulated industries.
Remote Audits in the Age of COVID-19
Amid the ongoing pandemic, groups like the European Commission (EC) and the International Accreditation Forum (IAF) have announced notified bodies (NBs) can conduct remote audits for k [...]
AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
Join us for a one-hour webinar focused on efficient management of postmarket challenges faced by medical device manufacturers marketing devices in the EU. DATE: Tuesday, [...]
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 expanded to reflect a highly applicable curve for adapting to any [...]
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 STATES, February 03, 2021 -- AssurX, Inc. (AssurX), a leader in qu [...]
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 devices that need to be certified to the new law. What should c [...]
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 companies are under pressure to ensure products are compliant with [...]
