MCRA has extensive experience successfully navigating FDA’s biocompatibility expectations for complex medical devices.
Our Biocompatibility Experience and Services
Biocompatibility testing is expensive, time consuming, and often an unexpected hurdle on the path to the international markets. International biocompatibility requirements have substantially increased with the implementation of the EU MDR and the publication of new biocompatibility standards ISO 10993-1:2018 and ISO 10993-18:2020. MCRA has deep knowledge of international biocompatibility regulatory requirements and the biocompatibility standards. Our experts specialize in finding the least burdensome biocompatibility evaluation pathway. We develop the most efficient combination of rationales, plans for biological testing & chemical characterization, and risk assessments to maximize our clients’ chances of success.
Instrumental to our success is collaborative, early interaction with preclinical test labs. In addition, MCRA’s independent perspective ensures that your biocompatibility test plan excludes any unnecessary testing.
MCRA offers the following biocompatibility services:
• Response to deficiencies from international regulators
• Biocompatibility strategy development for new devices, combination products, device changes, material supplier changes
• Biological evaluation plans (BEP) and biological evaluation reports (BER) compliant with ISO 10993-1:2018
• Gap assessments to the ISO 10993 series of standards
• EU Carcinogenic, Mutagenic, or Toxic for Reproduction and Endocrine Disruptors (CMR/ED) requirements
• Biological testing and chemical characterization plans
• Test article preparation
• Chemical Characterization (Extractables & leachables) testing design and remediation (ISO 10993-18)
• Toxicological risk assessment (TRA) planning and remediation
• Biological evaluation reports
• Rationales based on materials and manufacturing in lieu of biocompatibility testing
• Test report review
• Device materials selection
• Risk mitigation strategies for impurities and degradants
• US biocompatibility requirements (US Biocompatibility)