Medical Device Testing Services

We provide a focused range of Medical Device testing solutions that expedite your product approval process during your journey to market.

Filter our services by type:

Medical Device Cleaning Validation

Medical Device Cleaning Validation

We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.

  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-5
  • ASTM F3208-20
Medical Device Reprocessing Validation

Medical Device Reprocessing Validation

We validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.

  • 4-8 week typical lead time
  • Custom test rigs
  • Bespoke testing setups
  • Cleaning, Disinfection & Sterilisation cycles
  • AAMI TIR30  / ANSI/AAMI ST98:2022
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Medical Device Reprocessing Instructions Development

We develop cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.

  • 2-4 week typical lead time
  • Cleaning, Disinfection & Sterilisation
  • IFU Development
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-5
Extractables & Leachables (E&L) Testing

Extractables & Leachables (E&L) Testing

We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.

  • 2-4 week typical lead time
  • ISO 10993-18
  • USP<1663>/<1664>, USP <665>/<1665>
  • Aligned with MDR and FDA guidance
  • Custom Extractables Study Design
R&D Medical Device Testing Support

R&D Medical Device Testing Support

Whether you’re refining a prototype, investigating a failure mode, or pushing the limits of what your device can do, we’re here to provide the technical testing support you need.

  • 4-8 week typical lead time
  • Custom test rigs
  • Bespoke testing setups
  • Proof-of-concept testing
  • Cross-disciplinary support
Accelerated Aging Testing

Accelerated Aging Testing

We perform accelerated aging testing and real time
ageing studies to determine how a products behave
under normal storage/use conditions over long periods
of time.

  • 3-4 week typical lead time
  • ASTM F1980 Sterile Barrier Systems & Medical Devices
  • ISO 11607 Packaging for terminally sterilized medical
    devices
IEC 60601-1-2 EMC Testing

IEC 60601-1-2 EMC Testing

We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2

  • 2-4 week typical lead time
  • 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 Testing and Certification

IEC 60601-1 Testing and Certification

We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series

  • 4-6 week typical lead time
  • 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 Brazilian market
Medical Device Sterilisation Validation

Medical Device Sterilisation Validation

We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.

  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • BS EN ISO 17664-1:2021
  • ISO 14937:2009
  • BS EN ISO 17665:2024
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Medical Device Disinfection Validation

We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.

  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-1/2
  • AAMI TIR12:2020
ISO 10993-23 Test for Irritation

ISO 10993-23 Test for Irritation

We offer ISO 10993-23 tests to determine irritation potential of their devices without the need for animal testing.

  • 2-4 week typical lead time
  • Good Laboratory Practice GLP study
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-23 – test for irritation – in vitro methods
ISO 10993-5 Cytotoxicity Testing

ISO 10993-5 Cytotoxicity Testing

We offer ISO 10993-5 cytotoxicity in vitro tests which evaluate biological risks within the chemical make-up of a medical device.

  • 2-4 week typical lead time
  • Good Laboratory Practice GLP study
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-5 – cytotoxicity – in vitro methods
Medical Device Biological Evaluation Report

Medical Device Biological Evaluation Report

We produce a report which is a collective summary of all data used to assess the biocompatibility of your medical device.

  • 2-3 week typical lead time
  • ISO 10993-1 – Biological evaluation of medical devices
  • Meets the requirements of FDA / MDR
  • Provides comprehensive ISO10993 report
  • Completed by in-house toxicologist (competent person)
Medical Device Biological Evaluation Plan

Medical Device Biological Evaluation Plan

We complete Biological Safety Evaluation, following ISO 10993-1 standard to address possible biological hazards and risks associated with the clinical use of your medical device.

  • 2 week typical lead time
  • 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)
Disinfection Sprays for Medical Devices

Disinfection Sprays for Medical Devices

We will determine the efficacy of your medical device disinfectant spray, as well as perform Material Compatibility tests.

  • 2-3 week typical lead time
  • UKAS accredited
  • Bactericidal, fungicidal, yeasticidal
  • Sporicidal, mycobactericidal
  • Virucidal
Disinfection Wipes for Medical Devices

Disinfection Wipes for Medical Devices

We will determine the efficacy of your medical device disinfectant wipe, as well as perform Material Compatibility tests.

  • 2-3 week typical lead time
  • UKAS accredited
  • Bactericidal, fungicidal, yeasticidal
  • Sporicidal, mycobactericidal
  • Virucidal
Air-Purification Product Testing

Air-Purification Product Testing

We offer tests which evaluate the efficacy of your air purification systems against our in-house methods, based on international standards.

  • 2-3 week typical lead time
  • Airborne contamination
  • Particle counts
  • Volatile Organic Compounds (VOC)
  • Air circulation
Whole Room Disinfection Systems Testing

Whole Room Disinfection Systems Testing

We test a wide range of technologies including disinfection robots, fogging machines, electrostatic hand sprayers.

  • 4-5 week typical lead time
  • EN17272:2020 – UKAS accredited
  • Cycle development / range finder tests
  • Distribution test
  • Biocide monitoring / safety tests
UV-C Technology Efficacy Testing

UV-C Technology Efficacy Testing

We assess the efficacy of UV-C light technology units and systems against the latest industry standards.

  • 2-4 week typical lead time
  • 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
Label Durability Validation

Label Durability Validation

We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.

  • 2-4 week typical lead time
  • Finished Product Testing
  • Bulk Product/Batch Testing
  • Life Cycle Testing
  • Verification Testing
Highly Accelerated Life Test

Highly Accelerated Life Test

We use in-house methods and technologies to repeatedly operate devices and prototypes without human intervention to provide crucial data in accelerated time.

  • 4-6 week typical lead time
  • Medical device expected service life testing
  • Material compatibility testing
  • Basic electrical safety & essential performance testing
  • Final product & prototype testing
Reprocessing Validation for Class 1r Medical Devices

Reprocessing Validation for Class 1r Medical Devices

We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.

  • 4-week typical lead time
  • BS EN ISO 15883-5:2021
  • BS EN ISO 15883-2:2009
  • BS EN ISO 17665-1:2006
  • 17025 UKAS accredited
Pre-compliance IEC 60601-1 Testing

Pre-compliance IEC 60601-1 Testing

We test your device, mitigating the cost of repeated compliance testing by evaluating potential non- compliances.

  • 2-3 week typical lead time
  • Documentation review
  • Critical Component and Insulation Review
  • Laboratory Testing
  • HALT
Medical Device Material Compatibility Testing

Medical Device Material Compatibility Testing

We analyse test item materials at both sample and product level to assess process compatibility.

  • Starts from 2-3 week typical lead time
  • Spray 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
Medical Device Bioburden Testing

Medical Device Bioburden Testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

  • 3-4 week typical lead time
  • TYMC “Total yeast mould count”
  • TAMC “Total aerobic count”
  • Specific pathogen testing
  • ISO 11737 & ISO 11137 sterilisation method validation
Medical Device Biocompatibility Testing

Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

  • 4-5 week typical lead time
  • Biological Evaluation Plan & Report
  • In Vitro & In Vivo methods
  • Extractables & Leachables (E&L) Studies
  • Also testing after cleaning, disinfection & sterilization
Clinical Evaluation

Clinical Evaluation

We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.

  • 8-10 week typical lead time
  • Comply with Article 61 and Part A of Annex XIV of MDR
  • Pre- and Post-market clinical data
  • Following MEDDEV 2.7.1 Rev 4
  • CE & UKCA

Our approach is your success story