Medical Device Biological Evaluation Report
We compile a comprehensive report that consolidates all data used…
- ISO 10993-1 - Biological evaluation of medical devices
- Meets the requirements of FDA/MDR
- Provides comprehensive ISO 10993 report
- Completed by in-house toxicologist (competent person)
ISO 10993-23 Test for Irritation
We offer ISO 10993-23 in vitro irritation testing to assess…
- Good Laboratory Practice GLP study
- Biological Evaluation Plan and Report
- ISO 10993-23 - test for irritation - in vitro methods
Extractables & Leachables (E&L) Testing
We provide comprehensive Extractables & Leachables (E&L) testing to detect…
- ISO 10993-18
- USP<1663>/<1664>,USP<665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Stufy Design
ISO 10993-5 Cytotoxicity testing
We offer ISO 10993-5 in vitro cytotoxicity tests under GLP…
- Good Laboratory Practice GLP study
- Biological Evaluation Plan
- Biological Evaluation Report
- ISO 10993-1 - cytotoxicity- in vitro methods
Medical Device Biocompatibility Testing
We provide testing services that assess cytotoxicity and evaluate biological…
- Biological Evaluation Plan and Report
- In Vitro and InVivo methods
- Extractables and Leachables (E&L) Studies
- Also testing after cleaning, disinfection & Sterilization
Medical Device Biological Evaluation Plan
We conduct Biological Safety Evaluations in accordance with ISO 10993-1…
- ISO 10993-1 - Biological evaluation of medical devices
- Meets the requirements of FDA/MDR
- Provides comprehensive ISO10993 testing plan
- Completed by in-house toxicologist (competent person)
IEC 60601-1 Testing and Certification
We assist you with testing and certifying your medical devices…
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- US-NRTL certification according to ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No.60601-1
- INMETRO certification for access to the Brazalian market