Top 10 Traits of World Quality Management Leaders
It’s World Quality Month (WQM) and that means taking time to reflect and recogni [...]
18
11, 2019
6
11, 2019
Have You Transitioned to Quality 4.0?
Quality 4.0 focuses on a collaborative approach to quality to ensure that qualit [...]
23
10, 2019
QMS Validation 101: SDLC vs. STLC Methodologies and Relationships
Validation is integral part of Good Manufacturing Practices (GMPs) and covers al [...]
21
10, 2019
Advanced Medical Solutions Selects AssurX Quality Management and Regulatory Compliance Software
AssurX Platform will Automate and Standardize Quality Operations in the UK, Neth [...]
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 [...]
27
08, 2019
Validation of a regulated computer system – what’s the big deal?
Anyone who has been part of a successful validation effort for a regulated compu [...]
15
08, 2019
EU MDR Compliance: An Opportunity for Change
EU MDR Compliance: The new European device regulation will bring about impactful [...]
