AssurX EU MDR Webinar Follow-Up: 10 FAQs for Tackling EU MDR Data Management
Last month, AssurX hosted a webinar entitled “Who Moved my MDR? Assessing Organi [...]
4
10, 2019
4
09, 2019
Cybersecurity for Medical Devices – Who’s Accountable?
Cybersecurity for Medical Devices is on the agenda for the U.S. Food and Drug Ad [...]
15
08, 2019
EU MDR Compliance: An Opportunity for Change
EU MDR Compliance: The new European device regulation will bring about impactful [...]
18
06, 2019
FDA to Sunset Alternative Summary Reporting (ASR) Program
The FDA has announced an end to the alternative summary reporting (ASR) program [...]
17
04, 2017
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process [...]
11
04, 2017
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined [...]
20
03, 2017
Avoid QMS Automation Failures with the Right Implementation Team
Even after decades of eQMS availability, a staggering number of projects still s [...]
16
12, 2016
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufac [...]
14
07, 2015
FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]
19
06, 2015
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
Tamar June, VP, Strategic Marketing, AssurX, Inc. Looks like it's crunch time [...]
