Clinical Evidence Engineering for Medical Devices
We transform clinical data into coherent scientific evidence frameworks – built for clinical credibility, academic scrutiny, and regulatory defensibility. Augmented by AI. Rooted in expertise.
Evidence Engineering
We transform fragmented clinical data into a “Single Source of Truth.” By engineering robust evidence frameworks, we ensure your orthopedic data is ready for every critical touchpoint—from bulletproof regulatory submissions to high-impact academic publications and clinical marketing initiatives.
Scientific Strategy
We bridge the gap between complex engineering data and regulatory-defensible clinical narratives. By applying deep orthopedic expertise to every protocol and report, we ensure your clinical logic is aligned with the latest “State of the Art” and survives the most rigorous Notified Body scrutiny.
Regulatory Intelligence
Navigating the EU MDR ‘Regulatory Crucible’ requires foresight. We leverage AI-augmented analysis to monitor changing requirements in real-time, ensuring your clinical evidence remains ahead of the curve
How AMR works
AMR is a science-driven clinical evidence consultancy supporting medical device manufacturers and academic institutions.
We help generate, analyse, and communicate robust clinical evidence — for scientific credibility, clinical relevance, and regulatory defensibility.
Our work starts with clinical questions, not regulatory checklists.
Who we work with:
- Medical Device Manufacturers: from early clinical strategy to post-market evidence under MDR.
- Universities & Academic Centers: study design, statistical analysis, registry research, and manuscript development.
- Clinicians & Surgeons: scientific support for investigator-initiated studies, registries, and high-impact publications.
Core Domains:
- Orthopaedic & Dental Implant Technologies
- Hip, knee, spine, fixation systems, and implantable dental devices.
- Clinical Research & Evidence Generation
- Prospective studies, registry analytics, and real-world evidence.
- Scientific Interpretation & Communication
- Turning complex data into credible scientific narratives — for journals, conferences, and peer review.
- Regulatory-Defensible Clinical Strategy
- Aligning strong clinical science with MDR and Notified Body expectations.
AMR operates at the intersection of clinical science, data analytics, scientific communication, and regulation.
We are a clinical evidence partner — not a documentation factory.
Principal Consultant
Peter Fennema is an orthopaedic clinical evidence expert in medical devices and founder of AMR Advanced Medical Research, a consultancy established in 2013. A clinical epidemiologist by training, he specializes in the generation and communication of robust clinical evidence—spanning study design, registry analytics, and MDR clinical evaluation—for high-risk medical devices. His work integrates clinical science, data analytics, scientific communication, and regulatory strategy, with a particular focus on responsibly applying AI to enhance scientific and regulatory processes.
Strategic Consultation
Clinical and regulatory support for orthopedic medical devices under MDR.
Direct contact:
AMR Advanced Medical Research GmbH
Hofenstrasse 89b
8708 Männedorf
Switzerland