The new form Manufacturer Investigation form for reportable events in EU is mandatory starting this November 2025. MDR Compliance (Article 120) / New Manufacturer’s Investigation Form Non-serious events demonstrating a trend or significant risk management changes that occur during post…
Medical device companies in Europe and pharmaceutical companies share a unique business challenge, inability to innovate production processes because of currently insurmountable barriers to change. For example, Chlorine Dioxide sterilization can be validated and implemented as a replacement sterilization process…
Manufacturers marketing product in the European Economic Area (EEA) must now complete registration in EUDAMED. Manufacturers need to register the official URL where e-IFUs are hosted in the EU's EUDAMED database. EUDAMED eIFU Compliance – Service Provider Available >QMS Velocity…
The extension of Medical Device Regulation (MDR) deadlines under (EU) 2023/607 (Ref. MDCG 2021-25 for additional guidance) has led many manufacturers to breathe a sigh of relief. With additional time granted for compliance, some organizations may feel a reduced sense…
The recent extension of In Vitro Diagnostic Regulation (IVDR) deadlines under (EU) 2024/1860 has led many manufacturers to breathe a sigh of relief. With additional time granted for compliance, some organizations may feel a reduced sense of urgency. But does…
Developing true interdependence between clinical teams and business-sustaining functions is a challenge. The learning curve is steep—particularly when navigating the complexities of ISO 14971 and ISO 24971—and failure to properly integrate risk management updates can lead to compliance liabilities. One…
For MDR or IVDR remediation, gap assessments are a difficult process and results in a body of work without making any progress on actual remediation. Although gap assessments are an important tool to review gaps and provide evidence of compliance, the…
With MDR implementation, companies are linking risk management and complaint systems and post market surveillance system. Many US companies were already doing this because FDA inspections check to see if complaints, CAPA, and risk analysis are linked. “Product and…
A likely cause of a nonconformance (NC) before and after IVDR or MDR accreditation is associated with tighter Vigilance reporting requirements. What changed? EU2017 746 IVDR Article 82 (2) / EU2017 745 MDR Article 87 (3) “Manufacturers shall report any…
Although FDA and MDR allow eIFU to be used, the Australian TGA has provided the clearest guidelines on requirements of eIFU. The first eIFU platform I worked on and implemented was over twenty years ago. If requirements are well defined,…