Biological Safety
All medical devices with direct or indirect contact with patients must be subjected to a biological and toxicological evaluation. Key2Compliance helps you to plan, perform and document the biological evaluation, with the safety of patients in mind.
We also provide support regarding other aspects of pre-clinical verification/validation activities (Technical Product Management), such as transportation validation, packaging validation, shelf life, cleaning validation, bioburden and reprocessing of devices.
Key2Compliance can help you with:
- Biological evaluation plans and reports (“BEP and BER”)
- GAP-analysis of your existing BEP and BER
- GAP-analysis against updated standards in the ISO 10993-series, MDR and/or guidelines for specific global markets
- Toxicological risk assessments of chemicals, processing agents and device materials (stand-alone, or as part of BEP)
- Systematic literature reviews (toxicology, chemistry and materials)
- Coordination of chemical/in vitro/in vivo studies with appropriate test laboratory
- Coordination of simulated use / bench testing of your device
- Biological evaluation of combination devices
- In-house and public trainings on biological evaluation of medical devices
- Standard Operation Procedures (SOPs) for the biological evaluation process
- Test design, plans and reports for transportation validation, packaging validation, stability studies, cleaning validation, bioburden and reprocessing.
- Questions related to Good Laboratory Practice (GLP)
We provide you with both theoretical and practical expertise in all indicated areas.
The extent of our services is tailored to your needs, we can be everything from a discussion partner to documenting and coordinating the entire verification/validation activity.
We know what is needed – and we do it for you
- We support you hands-on in all aspects of the biological evaluation of medical devices, from choice of raw materials/components during the design phase to testing and documentation for the final device. We fulfill your regulatory needs both for MDD/MDR and global markets. The Biological Evaluation Plan and Report are important aspects of your Technical File which need to be updated when any change occurs regarding manufacturing or downstream processes, suppliers, materials, or updates standards and guidelines.
- We support you with other aspects of your verification/validation procedures and product maintenance, such as Technical Product Management, e.g. regarding transportation validation, packaging validation, stability studies (shelf life), cleaning validation, bioburden/cleanroom and reprocessing of devices.
- We work closely with our colleagues that are experts in QA/RA and Clinical development/Post Market Surveillance to assure that all of your processes within the company are streamlined in a cost-efficient way. We can help you be compliant – now and in the future!
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