Inside Our Heart Implant Project: From Bench to Bedside – Part 2 of 3
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...
Inside Our Heart Implant Project: Designing for Real-World Impact – Part 1 of 3
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...
Reporting and Post-Trial Activities in Clinical Investigations
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...
Site Selection, Monitoring, and Approvals in Clinical Investigations
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...
Essential Documentation for Clinical Investigations: Ensuring Compliance and Integrity
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...
Clinical Investigation Planning: Setting the Foundation for Regulatory Success
The Importance of Clinical Investigation Planning Under MDR When preparing to bring a medical device to market under MDR (EU 2017/745), one of the most critical steps is the planning of your clinical investigation. Regulatory authorities require manufacturers to...
Streamlining Your Path to Compliance: Expert BEP and BER 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...
Crafting a Comprehensive Biological Evaluation Report (BER) for MDR Compliance
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...
Mastering the Biological Evaluation Plan (BEP) for MDR Compliance
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...
Strategic Decisions: FDA vs. EU-MDR – Which Path to Take First?
Weighing Your Options: FDA vs. EU-MDR Choosing between FDA and EU-MDR approval is not just a regulatory decision—it’s a strategic choice that impacts your time-to-market, costs, and long-term compliance strategy. Each pathway presents unique benefits and...
