GLP Studies for Medical Devices
ISO 10993 BiocompatibilityGroupe supports Class II and Class III medical device manufacturers under MDR delivering GLP-certified ISO 10993 biocompatibility studies, from cytotoxicity screening to implantation and hemocompatibility testing.
Regulatory Context
Medical devices placed on the European market must comply with MDR (Medical Device Regulation). As part of the biological evaluation process, manufacturers are required to conduct a series of biocompatibility studies defined by the ISO 10993 standard series.
CER Groupe provides the full range of GLP-certified biocompatibility studies required to support your technical documentation and CE marking dossier - for both Class II and Class III devices.
ISO 10993 Biocompatibility Studies
Our ISO 10993 testing portfolio covers all major endpoints of the biological evaluation framework, conducted under GLP conditions by our team of PhD- and MSc-level scientists.
- Cytotoxicity - ISO 10993-5
- Sensitization and irritation / intracutaneous reactivity - ISO 10993-10, -23
- Systemic toxicity (acute, subacute, subchronic) - ISO 10993-11
- Material-mediated pyrogenicity
- Implantation studies / local tolerance - ISO 10993-6
- Hemocompatibility - ISO 10993-4
- Genotoxicity, carcinogenicity, reproductive toxicity - when required
Why CER Groupe for Your Medical Device Studies
Our expertise in biocompatibility testing is backed by decades of GLP experience and an integrated analytical platform - ensuring reliable, reproducible results that meet the highest regulatory standards.
- GLP-certified since 1993
- End-to-end study management - from protocol design to final report
- PhD- and MSc-level scientists dedicated to each study
- Full adherence to OECD Principles of Good Laboratory Practice
- Transparent communication and dedicated project management