Ensuring Biological Safety in Medical Device Development
Biocompatibility is a critical consideration for any medical device intended to come into contact with the human body. The ISO 10993 series sets the internationally recognized standards for evaluating the biological safety of medical devices, forming the cornerstone of biological risk assessments under MDR (EU 2017/745) and IVDR. At MDS, we provide ISO 10993 testing services that help manufacturers ensure regulatory compliance and, most importantly, patient safety.
A Comprehensive Approach to Biocompatibility
Our testing services begin with the Biological Evaluation Plan (BEP). This strategic document reviews the device and its materials, identifies potential biological risks, and outlines appropriate testing and evaluation strategies. With a well-defined BEP, you have a clear path to compliance and a thorough understanding of your device’s biological risk profile.
The next step is comprehensive biocompatibility testing. We manage in vivo and in vitro biological tests, chemical characterization, and toxicological evaluations—tailoring our approach to your device’s materials and intended use. Production residuals, sterilization processes, and batch release testing are also evaluated to ensure no harmful residues or inconsistencies compromise the device’s safety.
Focus on Chemical Characterization and Sterilization Validation
Chemical characterization and analysis form a critical part of our biocompatibility services. We ensure that any potential leachables, extractables, or residuals are identified and properly assessed for biological risk. Our services also include sterilization validation, verifying that your chosen sterilization method does not degrade materials or introduce harmful residues that would impact patient safety.
Documentation for Regulatory Confidence
Once testing is complete, we compile all data into a comprehensive Biological Evaluation Report (BER). This detailed report integrates testing results, literature reviews, and risk assessments, serving as essential evidence of your device’s safety for regulatory submissions and conformity assessments.
Why Choose MDS for ISO 10993 Testing?
At MDS, we combine deep expertise in biocompatibility standards with a commitment to tailored solutions. We:
- Provide guidance throughout the entire biological evaluation process
- Customize testing to your device’s specific risk classification and materials
- Prioritize safety and regulatory alignment to support a smooth approval process
Start Your Path to Biocompatibility Compliance
With ISO 10993 testing services from MDS, you gain a reliable partner in your regulatory journey. We’re dedicated to helping you meet biological safety requirements, streamline testing, and support patient-focused innovation.
To learn more about how our services can support your device compliance, contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
