Medical Devices

Explore what makes us unique

Woman Receiving Radiation Therapy, Radiotherapy Treatments for Cancer

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
Medical Research

Performance evaluation of in-vitro diagnostics

Our services include:

  • Complete Programme Management
  • Regulatory submissions
  • Scientific Advice
  • Protocol and report writing

 

A person putting a person into a MRI