AssurX Blog
Straight talk for regulated industries.
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections aft [...]
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. According to a 2022 Medical Device Coordination Group (MDCG) po [...]
Overcoming Common Challenges of Customer Quality Complaint Handling
From food and beverage to electronics to CPG, there’s not a single type of manufacturer that’s immune to customer complaints. While customer complaints are never something an organizat [...]
Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety
From Listeria in ice cream to E. coli in lettuce, there’s one central question in any foodborne illness outbreak: where did the contamination happen? It’s a simple question with often [...]
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activities for life sciences companies. It’s also the single largest expense for many companies when they autom [...]
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats also grow. The U.S. Food and Drug Administration (FDA) expects medical device manufacturers to fully inco [...]
