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...
by adminReaktio | Feb 13, 2025 | Medical Device Services
Understanding the Biological Evaluation Report (BER) Ensuring the biological safety of a medical device is a crucial aspect of meeting the European Medical Device Regulation (MDR, EU 2017/745) requirements. At the heart of this process is the Biological Evaluation...
by adminReaktio | Feb 6, 2025 | Medical Device Services
Understanding the Biological Evaluation Plan (BEP) Ensuring the biological safety of a medical device is a fundamental requirement under the European Medical Device Regulation (MDR, EU 2017/745). A core component of this process is the Biological Evaluation Plan...
