Biological Evaluations & Toxicology

A requirement for all medical devices with direct or indirect contact with patients, regardless of risk class, is that there must be a biological evaluation report prepared for the product.

If you miss that part, it might cost you. Key2Compliance® helps you choose the right methods and carry out the right studies. Everything for the safety of patients.

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We know what needs to be done – and we do it for you

In order to meet the requirements of the EU Regulation on Medical Devices (MDR), all medical devices must undergo a biological evaluation. The purpose is to determine the extent to which a product is affected by contact with human tissue, so that any safety risks for patients are identified and eliminated early in the process.

The biological safety evaluation is often complex since it includes a balance between design, choice of raw materials or components, application and functionality, as well as control of the production process, development and production costs and time-to-market. It consists of a number of tests and considerations, which together ensure that the final product will be suitable for its intended purpose. The type of testing required for a particular material is determined by the product’s intended contact with the patient and the time of contact. The standard series ISO 10993 for biocompatibility in combination with ISO 14971 forms the basis for the biological safety plan.

Key2Compliance® is a committed partner with good knowledge of current regulations, existing test methods and strategies. We help you write the biological evaluation plan and report. In addition to internal expertise, we have an extensive network and collaborate with specialists and contract laboratories of various kinds all around the world.

Key2Compliance® helps you to:

  • Write biological evaluation plans and reports
  • Evaluate raw materials
  • Do chemical characterization or review data from chemical characterization
  • Coordinate studies to the appropriate test laboratory
  • Make toxicological risk assessments
  • Conduct internal and external training on biological evaluation of medical devices
  • Write Standard Operation Procedures (SOPs) for the biological evaluation process
  • Develop evaluation plans and report templates
  • Be a discussion partner when you establish internal routines
  • Act as a contractor for Notified Bodies when reviewing biological safety