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...
by Waltteri Sorvisto | May 8, 2025 | Medical Device Services
Showcasing Our Expertise at the Copenhagen Health Tech Summit What a way to begin the month of May! MDS was thrilled to attend the Copenhagen Health Tech Summit 2025, hosted by Health Tech Hub Copenhagen. The event brought together thought leaders, innovators, and...
by Waltteri Sorvisto | Apr 24, 2025 | Medical Device Services
From Documentation to Regulatory Readiness This is the final entry in our three-part series on the development of a mitral valve heart implant. So far, we’ve taken you from the earliest design stages through preclinical and human clinical trials. In this final post,...
