
Whole Room Chemical Automated Disinfection
We test a diverse range of technologies, including disinfection robots, fogging machines, and electrostatic hand sprayers.
We’ve relied on Test Cert for multiple medical device testing projects, and they’ve never disappointed. Their team has deep knowledge of ISO 21530 and other relevant standards. Their timely, well-documented test reports helped us meet both local and international regulatory requirements with ease.”
– Dr. Ayesha Malik, Regulatory Affairs Manager, Meditech Solutions.
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Service FAQ
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.
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.
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
What are the payment methods here?
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.
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.
Related tests
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)