Medical Devices

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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