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...
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...
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...
