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 be costly. Key2Compliance® helps you to plan and perform the biological evaluation including choosing and carrying out the appropriate studies. Everything with safety of patients in mind.
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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 protect of humans from potential biological risks arising from the use of medical devices.
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 evaluation plan.
Key2Compliance® is a committed partner with good knowledge of current regulations, existing test methods and strategies. We help you to 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® provides the following services:
- Write biological evaluation plans and reports
- Evaluate raw materials
- Make toxicological risk assessments of ingoing materials and/or extractables/leachables.
- Coordinate chemical/in vitro/in vivo studies to the appropriate test laboratory
- 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