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 Waltteri Sorvisto | Apr 3, 2025 | CRO
Completing the Clinical Investigation with Confidence A clinical investigation doesn’t end when the last patient completes the study. The final phase—reporting and post-trial activities—is just as critical as planning and execution. This phase ensures your study meets...
by Waltteri Sorvisto | Mar 27, 2025 | CRO
Building a Compliant Clinical Investigation from the Ground Up Before a clinical investigation can begin, several critical elements must be in place to ensure regulatory compliance, data quality, and patient safety. Under MDR (EU 2017/745) and ISO 14155, the processes...
by Waltteri Sorvisto | Mar 20, 2025 | CRO
The Role of Documentation in MDR-Compliant Clinical Investigations Proper documentation is the backbone of every clinical investigation. Under MDR (EU 2017/745) and ISO 14155, medical device manufacturers are required to maintain a comprehensive set of documents to...
