Services available for Incubators

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 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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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.

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