Medical Devices
We support you with consultancy and clinical trials in medical devices according to current legislation (e.g., Directive 2007/47/EC and DIN EN ISO 14155, 21 CFR Parts 800-1050).
ABX-CRO has extensive experience in medical device studies including:
- Implantable devices
- Drug / device combinations
- Radiolabelled devices
Performance evaluation of in-vitro diagnostics
Our services include:
- Complete Programme Management
- Regulatory submissions
- Scientific Advice
- Protocol and report writing