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,...
by Waltteri Sorvisto | Apr 16, 2025 | Medical Device Services
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...
by Waltteri Sorvisto | Apr 10, 2025 | Medical Device Services
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 ultimately...
by adminReaktio | Apr 2, 2025 | Medical Device Services
Key Aspects of Our Biological Evaluation Services Biological Evaluation Plan (BEP) We begin with the creation of a structured BEP outlining the assessment strategy for your device. This includes identification of potential biological hazards, applicable endpoints, and...
by adminReaktio | Feb 20, 2025 | Medical Device Services
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 to...
