Services available for Class IR Instruments

Clinical Evaluation

Clinical Evaluation

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

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  • 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
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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.

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  • 4-5 week typical lead time
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-5 – cytotoxicity – in vitro methods
  • ISO 10993-23 Tests for irritation – in vitro methods
  • Also testing after cleaning, disinfection & sterilization
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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.

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  • 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
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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.

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  • 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
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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.

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  • 4-week typical lead time
  • BS EN ISO 15883-5:2021
  • BS EN ISO 15883-2:2009
  • BS EN ISO 17665-1:2006
  • UKAS accredited
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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.

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  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • AAMI ST98/ISO 15883-5
  • Validated via residual analyte detection (Protein & ATP)
  • High/Low level disinfection validation to AAMI TIR-12
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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.

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  • 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
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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.

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

related Medical device resources related to Medical Device Biological Evaluation Plan View resources
  • 2-3 week typical lead time
  • ISO 10993-1 – Biological evaluation of medical devices
  • Meets the requirements of FDA / MDR
  • Provides comprehensive ISO10993 testing plan
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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.

related Medical device resources related to Medical Device Biological Evaluation Report View resources
  • 2-3 week typical lead time
  • ISO 10993-1 – Biological evaluation of medical devices
  • Meets the requirements of FDA / MDR
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