Clinical Evidence Consulting for Orthopedic and Dental Medical Devices according to EU MDR
AMR Advanced Medical Research GmbH
Männedorf (Switzerland)New on Amplifa
About AMR Advanced Medical Research
AMR Advanced Medical Research GmbH is an independent European Contract Research Organization (CRO) based in Männedorf on Lake Zurich. The company, founded in 2013 by Peter Fennema, offers scientific services to medical device manufacturers and academic research institutions, specializing in orthopedic and dental implants such as hip, knee, and spinal systems, as well as dental implants. The range of services includes study design and protocol development, Clinical Trial Management and Monitoring in Europe, Clinical Evaluation Reports (EU MDR), literature reviews, biostatistics, registry analytics, and Real-World Evidence, as well as Scientific Writing and regulatory strategy including Notified Body Support. Additionally, the company offers marketing and management consulting in the healthcare sector. AMR sees itself as a clinical evidence partner at the intersection of clinical science, data analysis, scientific communication, and regulation.
- Site
- Männedorf
- Processes
- Clinical Evidence / Clinical Evaluation (EU MDR), Study Design & Statistical Analysis, Regulatory Intelligence / EU MDR Strategy, Medical Writing / Scientific Communication, Clinical Trial Management & Monitoring, Clinical Study Design and Protocol Development, Clinical Trial Management and Monitoring (Europe), Clinical Evaluation Reports (EU MDR)
- Founded
- 2013
- Employees
- 2–10
- Industries
- Medical Technology (Orthopedics and Dental Implants), Pharmaceutical Industry, Academic Research Institutions
- 01
Clinical Question and Strategy
- 02
Study Design and Protocol Development
- 03
Data Collection and Trial Management
- 04
Statistical Analysis and Registry Analytics
- 05
Scientific Writing and Clinical Evaluation (EU MDR)
- 06
Regulatory Support up to Notified Body
Sites
Männedorf
CHHeadquarters, Consulting
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Clinical Evidence / Clinical Evaluation (EU MDR)Engineering | – | – | – | – | – |
| Study Design & Statistical AnalysisEngineering | – | – | – | – | – |
| Regulatory Intelligence / EU MDR StrategyEngineering | – | – | – | – | – |
| Medical Writing / Scientific CommunicationEngineering | – | – | – | – | – |
| Clinical Trial Management & MonitoringEngineering | – | – | – | – | – |
Additional services
History
- 2013
Founding of AMR Advanced Medical Research by Peter Fennema in Männedorf, Switzerland