Medical Devices
ACM’s medical device team has combined over 16 years of experience managing and monitoring pre-market and post market medical device trials with a focus on the indications cardiovascular disease, hypertension and joint diseases.
Medical device trials are conducted according to ICH GCP and Medical Device Regulations (EN ISO 14155 , MEDDEV Guidelines, National Regulations).
Our services include:
- Regulatory guidance & advice with competent authorities in Germany, Austria and Switzerland (DACH)
- Competent authority dossier preparation
- Competent authority dossier submission and tracking
- EC dossier preparation for medical devices
- EC dossier submission and tracking
- Clinical Investigational Plan development
- Patient informed consent development & review
- Development of guidelines and procedures
- Investigational site feasibility assessment
- Investigational site training with medical devices
- Technical support for medical device usage during study conduct
- Independent QA function for medical device trials
- Support with SAE reporting to competent authorities
