Bringing a medical device to the European market requires more than innovative technology — it demands meticulous documentation and clear evidence of safety and performance. Under the EU Medical Device Regulation (MDR 2017/745), your Technical File and Clinical...
In the evolving landscape of health technology, making informed decisions requires more than innovation—it demands strategic insight. Whether you’re an investor evaluating a new opportunity, a startup preparing for funding, or a procurement team assessing a new...
In the world of medical devices under EU MDR (EU 2017/745), the clinical evaluation process is a cornerstone of demonstrating safety and performance. At its heart are two interlinked documents: the Clinical Evaluation Plan (CEP) - which defines how you’ll gather...
Biological safety remains a critical part of bringing a medical device to market under EU MDR (EU 2017/745). Two documents in particular matter: the Biological Evaluation Plan (BEP), which lays the groundwork for identifying and managing biological risks; and the...
For many medical device companies, the United States is not only one of the largest healthcare markets in the world—it’s also a gateway to global opportunities. FDA clearance or approval is widely recognized as a gold standard in medical device regulation, and...
When bringing a medical device to market, one of the most important strategic choices manufacturers face is deciding whether to pursue approval in the United States under the FDA or in the European Union under the EU-MDR. Both frameworks are globally respected, but...
Throughout this spring, we’ve seen firsthand how medical device companies navigate the complex landscape of MDR—not only during audits but in the day-to-day realities of quality system maintenance. One insight has become increasingly clear: even well-established...
This spring, our consultants at MDS have been deeply involved in several intensive regulatory milestones. We supported clients through multiple Stage 1 and Stage 2 MDR audits, and participated in the TDA (Technical Documentation Assessment) process for various...
The shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) represents a significant overhaul in the regulatory landscape for in vitro diagnostic medical devices within the European Union. This transition aims to enhance...
Ensuring Biological Safety in Medical Device Development Biocompatibility is a critical consideration for any medical device intended to come into contact with the human body. The ISO 10993 series sets the internationally recognized standards for evaluating the...
