ISO 10993 TESTING SERVICES
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.
Comprehensive Testing Phases
Our testing phase involves a combination of in vivo and in vitro biological tests, chemistry tests, and toxicological risk assessments. We also incorporate scientific literature reviews to provide a thorough assessment of the device’s biological safety.
Chemical Characterization and Analysis
Chemical characterization and analysis form a crucial part of biocompatibility testing, ensuring that any potential risks associated with materials in contact with the body are identified and assessed.
Handling Production Residuals and Batch Releases
We manage production residuals and conduct batch release testing to ensure that each product batch meets stringent safety standards.
Sterilization Validation
Our services include sterilization validation, ensuring that sterilization processes are effective and do not adversely affect the biocompatibility of the device.
Biological Evaluation Report (BER)
After completing all tests, we compile the results into a comprehensive Biological Evaluation Report (BER), documenting the findings and conclusions regarding the device’s biocompatibility.
WHY CHOOSE MDS FINLAND FOR ISO 10993 BIOCOMPATIBILITY TESTING?
Expertise in Biocompatibility Standards
Our team is well-versed in ISO 10993 standards, providing you with accurate and reliable testing services.
Tailored Biocompatibility Solutions
We offer testing services customized to the specific biological safety requirements of your medical device.
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.
ENSURING BIOLOGICAL SAFETY AND REGULATORY COMPLIANCE
With MDS Finland, you gain a partner who is 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 to meet regulatory requirements and ensure patient safety.
