Biological evaluation of medical devices should be carried out via a risk management process and in accordance with standards 10993-1 and 14971 of the International Organization for Standardization (ISO) (through the Annex B of ISO 10993-1).
The main objectives are:
- To perform biological evaluation of the potential biological hazards of a medical device as part of an overall safety assessment
- To conduct the evaluation within the framework of a risk management process in order to identify potential risk factors and any steps necessary to take to mitigate those risks
PLG’s typical services
PLG’s experts in the biocompatibility of medical devices can help customers achieve compliance with ISO 10993, harmonized for MDR, to ensure manufacturers meet their obligations to Art.10 of MDR.
Examples of activities already performed:
Our experts can also manage the transition of the technical files from the Medical Devices Directive regulation to the Medical Device Regulation requirements according to the list of harmonized standards for medical devices.
- Physical-chemical characterization of medical device materials and literature evaluation according to Annex C of ISO 10993-1:2018
- Assessment of biological risks as part of the risk management system according to Annex B of ISO 10993-1:2018
- Gap analysis of tests performed according to obsolete standards
- Evaluation of relevant end points already performed and identification of missing end points according to Annex A of ISO 10993-1:2018
- Test selection, if necessary
- Drafting of the biological evaluation plan and final biological evaluation report
- Support of the updating of standard operating procedures and templates according to a company’s quality management system