AMIPLANT GMBH
Your Service Partner for the Medical Device Industry
Our Competences
QUALITY MANAGEMENT & QUALITY ASSURANCE
We support you in implementing the requirements as per
- EN ISO 13485
- 21CFR Part 820
- Chinese FDA GMP
Technical Documentation & Medical Device Approval
Our Services:
Gap analysis (MDD/MDR, FDA), preparation/review of technical documentation, monitoring during approval processes, transition from MDD to MDR
Read moreRisk Management & Usability Engineering
Our Services:
Gap analysis for risk management and usability engineering, preparation/implementation of risk management and usability engineering process, execution of risk analysis
Read moreProduct Development & Documentation
Our Services:
Do you have any ideas about new devices?
We are your well-versed partner in feasibility studies and implementation of your ideas
Read moreProject Management & Project Documentation
Our Services:
Support for your project team, assuming project responsibility (project management), project documentation according to your specifications
Read moreMedical Device Reporting & Medical Device Safety Officer
Our Services:
Development/implementation of an individual MDR process Assuming the task of medical device reporting, also as an external Medical Device Safety Officer (Section 30 of the Medical Devices Act – MPG)
Read moreClinical Research & Clinical Evaluation
Our Services:
Gap analysis for clinical evaluation according to MEDDEV 2.7/1 rev. 4, preparation of clinical evaluation plans (CEP) and clinical evaluation reports (CER), execution of literature research and clinical trials
Read moreAudit Preparation & Audit Support
Our Services:
Gap analysis, preparation of specifications and verification documents, back office organization, internal system audits, supplier audits
Read moreInterim Management & Restructuring
Our Services:
Temporary assumption of management tasks, development of optimization concepts, implementation of restructuring measures
Read moreWe guarantee quality and sustainability
Our Team
From left to right: PD Dr. Timo Eppig, Dr. Arthur Messner, Matthias Kolleck