Services available for Continuous Monitors

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
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
  • AAMI ST98/ISO 15883-5
  • Validated via residual analyte detection (Protein & ATP)
  • High/Low level disinfection validation to AAMI TIR-12
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 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
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