
Disinfection Wipes for Medical Devices
We will evaluate the performance of your medical device disinfectant spray in eliminating harmful microorganisms and carry out material compatibility testing to ensure it does not damage or degrade the surfaces it is applied to.
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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FAQ
What is TestCert?
TestCert is an independent, accredited medical device testing laboratory offering regulatory compliance, performance, and safety testing for a wide range of medical devices. We support clients from early R&D to final market approval.
Are you accredited?
Yes, we are accredited to ISO/IEC 17025 and follow Good Laboratory Practices (GLP). All our reports are accepted by notified bodies and regulatory agencies including the FDA, MHRA, and EU Notified Bodies.
Is confidentiality guaranteed?
Yes, we maintain strict confidentiality agreements to protect your intellectual property and proprietary information throughout the testing process.
What are your pricing and payment terms?
Pricing depends on the testing scope and complexity. After initial consultation, we provide a detailed quotation. Payments terms will be shared along with the quotation.
Do you offer retesting or additional testing services if needed?
Yes, we offer retesting services and additional tests as required, subject to an updated scope and 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.
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)