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
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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

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Risk 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

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Product 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

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Project Management & Project Documentation

Our Services:

Support for your project team, assuming project responsibility (project management), project documentation according to your specifications

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Medical 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)

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Clinical 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

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Audit Preparation & Audit Support

Our Services:

Gap analysis, preparation of specifications and verification documents, back office organization, internal system audits, supplier audits

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Interim Management & Restructuring

Our Services:

Temporary assumption of management tasks, development of optimization concepts, implementation of restructuring measures

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We guarantee quality and sustainability

Our Team

We are a dedicated team with many years of hands-on experience in medical technology and have a worldwide network of other experts for your tasks.

From left to right: PD Dr. Timo Eppig, Dr. Arthur Messner, Matthias Kolleck