Best Practices for 21 CFR Part 11 Compliance
With more modern-day compliance enforcement, life science manufacturers and dist [...]
19
12, 2019
11
12, 2019
Looking Ahead: 2020 Life Sciences Technology Trends
The Life Sciences industry has always been fast-paced and competitive. Changes a [...]
3
12, 2019
Elements of a Modern and Efficient Change Management System
An efficiently designed change management system clearly defines how strategies, [...]
4
10, 2019
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 [...]
26
09, 2019
FDA’s Fast Track Model for Software as a Medical Device (SaMD) Requires a Culture of Quality
Want to be part of FDA’s SaMD precertification program? Get your quality managem [...]
13
09, 2019
AssurX Demonstrating Regulatory & Quality Management Solutions at 2019 RAPS Conference
Next week, AssurX will be exhibiting at the annual Regulatory Affairs Profession [...]
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 [...]
9
07, 2019
AssurX Announces Patch Management Software for Greater IT and OT Asset Cybersecurity Control
Process-based Patch Management solution turns awareness into action Morgan Hill, [...]
25
06, 2019
EU MDR Rules Could Impact Medical Device Business Strategies
Changes in the European Union (EU) MDR and IVDR standards could force business c [...]
