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Clinical Evaluation

Clinical Evaluation

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

23 related Medical device resources related to Clinical Evaluation
  • 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.

26 related Medical device resources related to Medical Device Biocompatibility Testing
  • 4-5 week typical lead time
  • Biological Evaluation Plan & 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.

35 related Medical device resources related to Medical Device Material Compatibility Testing
  • 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.

15 related Medical device resources related to Pre-compliance IEC 60601-1 Testing
  • 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.

36 related Medical device resources related to Medical Device Cleaning Validation
  • 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.

29 related Medical device resources related to Highly Accelerated Life Test
  • 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.

24 related Medical device resources related to Label Durability Validation
  • 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.

8 related Medical device resources related to Medical Device Biological Evaluation Plan
  • 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)
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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.

8 related Medical device resources related to Medical Device Biological Evaluation Report
  • 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)
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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.

7 related Medical device resources related to ISO 10993-5 Cytotoxicity Testing
  • 2-4 week typical lead time
  • Offered as Good Laboratory Practice GLP study
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-5 – cytotoxicity – in vitro methods
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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.

5 related Medical device resources related to ISO 10993-23 Test for Irritation
  • 2-4 week typical lead time
  • Offered as Good Laboratory Practice GLP study
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • ISO 10993-23 – test for irritation – in vitro methods
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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.

36 related Medical device resources related to Medical Device Cleaning Validation
  • 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
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Medical Device Disinfection Validation

Medical Device Disinfection Validation

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

36 related Medical device resources related to Medical Device Disinfection Validation
  • 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
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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.

36 related Medical device resources related to Medical Device Sterilisation Validation
  • 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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