Biocompatibility & Safety

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As a medical device regulatory consultancy, Qserve has considerable in-house expertise in the biocompatibility and safety of medical devices . Submissions for approval of medical devices by regulatory authorities require biocompatibility compliance to assure the safety of the device or materials incorporated in the device. These assessments follow the ISO 10993 “Biological Evaluation of Medical Devices” series and the FDA guidance document, Blue Book Memorandum #G951 relating to this series. A material is considered to be biologically safe when it performs satisfactorily in the application under consideration. In practice this means it is biologically safe when its performance and application benefits outweigh any biological safety risks associated with it. Biological safety review and assessment is an essential part of the risk analysis required by the Medical Devices Directives (ANNEX I), using ISO 14971,”Medical devices - application of risk management to medical devices”.

The interaction between a biomaterial and its host environment (cells, tissues and tissue fluids) is dynamic and complex. Cells, through the action of, e.g., proteins, antibodies, or phagocytes can have an affect on the biomaterial and the biomaterial through, e.g., degradation and wear products and through leached substances can in turn affect the host tissue. Responses may be localized or systemic. The physiochemical, mechanical and morphological characteristics of the device may also impact on the host tissue.

This system is all the more complicated if the material has been designed to be biodegradable or to create a cellular response which in another situation would be considered "not acceptable". Recently, the biocompatibilty of devices has come under increasing scrutiny with the more widespread recognition that implanted biomaterials once considered to be relatively "inert" may release substances harmful to the patient.

Our highly experienced in-house industry professionals can provide you with the following services:

GAP analyses of your Regulatory Strategy for compliance Design of test strategies
Management of your study, or assistance with the project management of testing and trouble shooting
Your contact to the test houses
Search and review of all the available biological safety data concerning similar materials and products, in the public/scientific literature
Review of the suitability of available test data
Support and assistance with your risk analysis in respect to the identification of biological safety hazards and potential harms related to:

• Raw Materials 
• Packaging Materials 
• Production Processes 
• Final Product 
• Design Change processes
  

Selection of a biocompatibility safety test lab
Provision of an overall biological safety evaluation rational/report based on the outcomes and suitable for certification purposes world-wide Training in biological safety evaluation
If you would like more information, please contact us