Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assess [...]
1
09, 2022
25
08, 2022
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
10
08, 2022
Overcoming Common Challenges of Customer Quality Complaint Handling
From food and beverage to electronics to CPG, there’s not a single type of manuf [...]
26
07, 2022
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activit [...]
13
07, 2022
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
30
06, 2022
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
23
06, 2022
AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry
Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality man [...]
21
06, 2022
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the [...]
14
06, 2022
Why Calibration Management Software is Key to Proactive Quality
Unplanned downtime is an expensive issue, costing companies $50 billion every ye [...]
20
04, 2022
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
