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...
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...
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...
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...
From Animal Studies to First-In-Human Success Welcome back to our three-part series on how MDS brought a mitral valve heart implant from concept to clinical-stage testing. In Part 1, we covered the design, development, and preclinical planning. Now, we turn to the...
From Concept to Preclinical Readiness At MDS, we transform innovative ideas into market-ready medical devices. One standout example is our heart implant project—a journey that carried a complex concept from early design through verification, validation, and...
Understanding the Importance of BEP and BER in MDR Compliance Navigating the stringent requirements of the European Medical Device Regulation (MDR, EU 2017/745) requires a structured and comprehensive approach to biological evaluation. Two key documents essential...
