About Biological Evaluation
Biological evaluation is a “must” for all devices with direct or indirect contact with the patient. As regulatory demands increase, it is important to understand early in the development process what the requirements are. One way of performing the biological evaluation is to follow the ISO 10993 standard, different areas of the world might have slight differences or requirements, as an example, the 2016 FDA Guidance. For the manufacturer biological safety evaluation is often complex as it also means a balance between device design, selection of raw materials, application and functionality, control of the production process, control of development and production costs and time to market. Biological evaluation should always be done within a risk based approach. Furthermore, the documentation should be constantly updated to reflect the status of the device, such as, change of raw material supplier, change of intended use or updated due to complaints received related to biological safety. When standard changes occur, a gap-analysis should be performed to secure that the new standard requirements are met.
What Symbioteq can do
Symbioteq helps companies to write the Biological Evaluation Plan and Report for world-wide submissions. Beside in-house competence, we have an extensive network and co-operate with specialists and contract laboratories of various kinds around the world to obtain the required expertise needed. We are members of the standardization committee to continuously follow and also impact the standard development.
- Write the biological evaluation plan/strategy and report
- Assist in the choice of raw materials
- Coordinate studies to appropriate test laboratory
- Suggest chemical characterization and review chemical characterization data
- Write toxicological risk assessments
- In-house training
- Public courses on the Biological Evaluation of Medical Devices
- Write SOPs for the Biological evaluation process including Biological Evaluation Plan and Report Templates, be your discussion partner when setting up internal procedures
- Act as contractor for Notified Bodies reviewing Biological Safety Evaluations
And we are hosting the Symbioteq Biocompatibility of Medical Devices Conference every 2nd year.