by Waltteri Sorvisto | Sep 4, 2025 | FDA, Medical Device Services
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...
by Waltteri Sorvisto | Jun 26, 2025 | Medical Device Services
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...
by Waltteri Sorvisto | Jun 12, 2025 | Medical Device Services
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...
by Waltteri Sorvisto | Jun 5, 2025 | Medical Device Services
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...
by Waltteri Sorvisto | May 28, 2025 | Medical Device Services
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...
by Waltteri Sorvisto | May 15, 2025 | Medical Device Services
Powering Safety in Medical Electrical Equipment When developing medical electrical equipment, compliance with the IEC 60601 series is essential. This internationally recognized set of standards governs the safety and performance of medical devices that rely on...
