How our ISO 10993 Biocompatibility Testing Services compliment your Biological Evaluation:
Biological Evaluation Plan (BEP)
We begin by developing a Biological Evaluation Plan (BEP) which reviews the device and its materials, identifies potential biological risks, and suggests appropriate evaluations or testing strategies. This upfront planning ensures all relevant biological hazards are considered.
Comprehensive Testing Phases
Our testing phase involves a combination of in vivo and in vitro biological tests, chemistry tests, and toxicological evaluations. We also incorporate thorough scientific literature reviews to provide a comprehensive assessment of the device’s biological safety profile.
Chemical Characterization and Analysis
Chemical characterization and analysis form a crucial part of biocompatibility testing. We ensure that any potential risks associated with materials contacting the body (such as leachables or residuals) are identified and assessed.
Handling Production Residuals and Batch Releases
We manage production residuals and conduct batch release testing to ensure each production batch meets stringent biological safety standards. This step helps verify that manufacturing residues or variations do not introduce biocompatibility issues.
Sterilization Validation
Our services include sterilization validation, confirming that your sterilization processes are effective and do not adversely affect the device’s biocompatibility. We ensure that sterility is achieved without introducing toxic residues or degrading materials.
Biological Evaluation Report (BER)
After completing all tests, we compile the results into a comprehensive Biological Evaluation Report (BER). This report documents all findings and conclusions regarding the device’s biocompatibility and serves as the evidence of biological safety for regulatory submissions.
Why Choose MDS Finland for ISO 10993 Testing?
Expertise in Biocompatibility Standards
Our team is well-versed in ISO 10993 standards, providing you with accurate and reliable testing services. We understand the nuances of each part of the standard and apply best practices for biological safety evaluations.
Tailored Biocompatibility Solutions
We offer testing services customized to the specific biological safety requirements of your medical device. Whether your device is implantable, surface-contacting, or transient-contact, we adjust the test plan accordingly.
Focus on Safety and Compliance
We are committed to ensuring that your medical devices meet all necessary biocompatibility criteria, supporting their safe use and regulatory compliance. This focus on safety and regulatory alignment helps smooth the path to product approval.
ENSURING BIOLOGICAL SAFETY AND REGULATORY COMPLIANCE
With MDS Finland, you gain a partner dedicated to ensuring the biological safety of your medical devices. Our ISO 10993 testing services are an integral part of your device’s compliance journey, helping you meet regulatory requirements (MDR/IVDR General Safety and Performance Requirements for biocompatibility) and ensure patient safety.
