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Medical Device Biological Evaluation Report
- 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
- Good Laboratory Practice GLP study
- Biological Evaluation Plan and Report
- ISO 10993-23 - test for irritation - in vitro methods
Extractables & Leachables (E&L) Testing
- ISO 10993-18
- USP<1663>/<1664>,USP<665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Stufy Design
ISO 10993-5 Cytotoxicity testing
- Good Laboratory Practice GLP study
- Biological Evaluation Plan
- Biological Evaluation Report
- ISO 10993-1 - cytotoxicity- in vitro methods
Medical Device Biocompatibility Testing
- 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
- 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
- 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
IEC 60601-1-2 EMC Testing
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- IEC 60601-1-2:2020 (ed.4.1) - Medical electrical equipment
- Review and verification of EMC test plans, risk analysis, and user manuals
IEC 60601-1 Pre-Compliance Evaluation
- Documentation Review
- Critical Component and Insulation Review
- Laboratory Testing
- HALT
Highly Accelerated Life Test (HALT)
- Medical device expected service life testing
- Material compatibility testing
- Basic electrical safety and essential performance testing
- Final product and prototype testing
Whole Room Chemical Automated Disinfection
- EN17272:2020-UKAS accredited
- Cycle Development/ range finder tests
- Distribution test
- Biocide monitoring / Safety Tests
UV-C Technology Efficacy Testing
- BS8628:2023 - UKAS accredited
- 245nm UV-C, UVC LED, Far UVC (222nm)
- Safety and Output Measurement testing
- Simulated real-world use studies/ worst case studies
Air Purification Product Testing
- Airborne contamination
- Particle counts
- Volatile Organic Compounds (VOC)
- Air Circulation
Disinfection Sprays for Medical Devices
- UKAS accredited
- Bactericidal, fungicidal, yeasticidal
- Sporicidal, mycobactericidal
- Virucidal
Disinfection Wipes for Medical Devices
- UKAS accredited
- Bactericidal, fungicical, yeasticidal
- Sporicidal, mycobactericidal
- Virucidal
Medical Device Cleaning Validation
- Simulated use/accumulation study
- BS EN ISO 17664-1:2021
- ANSI/AAMI ST98/ISO 15883-5
- ASTM F3208-20
Medical Device Reprocessing Validation
- Custom test rigs
- Bespoke testing setups
- Cleaning, Disinfection and Sterlisation cycles
- AAMI TIR30 / ANSI/AAMI ST98:2022
R&D Medical Device Testing Support
- Customtest rigs
- Bespoke testing setups
- Proof-of-concept testing
- Cross-disciplinary support
Medical Device Material Compatibility Assessment
- Sprays tests, based on EN ISO 21530
- Soak tests, based on EN ISO 21530
- Contact tests, based on EN ISO 21530
- Wipe tests, based on BIFMA HCF 8.1-2017
Accelerated Aging Testing
- ASTM F1980 Sterile Barrier Systems and Medical Devices
- ISO 11607 PACKAGING for terminally sterilized medical devices
Our scale and reach to client Satisfaction
TestCert Provides the best Medical Device Testing experience
At Testcert, we are committed to delivering precise and reliable medical device testing services. Our focus on accuracy ensures that manufacturers, importers, and regulatory bodies can trust the results we provide. Backed by advanced technology, expert professionals, and strict quality protocols, we ensure every finding meets the highest standards of scientific integrity.
At Testcert, we are committed to delivering precise and reliable medical device testing services. Our focus on accuracy ensures that manufacturers, importers, and regulatory bodies can trust the results we provide. Backed by advanced technology, expert professionals, and strict quality protocols, we ensure every finding meets the highest standards of scientific integrity.
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Frequently Asked Questions
At Testcert, we value transparency and clarity. Browse through our FAQs to learn more about how we ensure accuracy, compliance, and quality in every test.
What types of medical devices does TestCert test?
We provide testing services for a wide range of medical devices including diagnostic equipment, therapeutic devices, implantables, in-vitro diagnostics, and more. Our services cover both electrical and non-electrical medical devices.
What testing standards do you follow?
TestCert adheres to international testing standards such as ISO 13485, IEC 60601 series, ISO 14971 for risk management, and other relevant ISO and FDA guidelines to ensure device safety, performance, and regulatory compliance.
What types of tests do you offer?
We offer a comprehensive suite of tests including:
- Electrical safety and performance testing
- Biocompatibility testing
- Mechanical and durability testing
- EMC (Electromagnetic Compatibility) testing
- Chemical and toxicological testing
- Sterilization validation
- Packaging integrity tests
How long does testing usually take?
Testing timelines depend on the scope and complexity of the device and tests required. On average, testing takes between 2 to 8 weeks. We provide estimated timelines during the project planning phase.
Do you assist with regulatory submissions?
Yes, TestCert offers consultancy to help you prepare technical documentation and test reports suitable for submission to regulatory authorities such as the FDA, CE marking bodies, and other international agencies.
How do I submit a device for testing?
You can contact our customer support team to discuss your requirements. Once the scope is defined, you will receive instructions for sample submission and a formal quotation.
Can TestCert test prototypes and pre-production devices?
Absolutely. We test both prototypes and production-ready devices to help you identify issues early and ensure compliance before mass production.
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At Testcert, we combine advanced testing technology with expert knowledge to deliver reliable and accurate results. Our modern facility is equipped to handle a wide range of medical device evaluations, ensuring your products meet regulatory standards with confidence.
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