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Services available for Biocides
Clinical Evaluation
We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.
21 related Medical device resources related to Clinical Evaluation
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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
Medical Device Biocompatibility Testing
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
23 related Medical device resources related to Medical Device Biocompatibility Testing
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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
Medical Device Material Compatibility Testing
We analyse test item materials at both sample and product level to assess process compatibility.
31 related Medical device resources related to Medical Device Material Compatibility Testing
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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
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
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- 2-3 week typical lead time
- Documentation review
- Critical Component and Insulation Review
- Laboratory Testing
- HALT
Medical Device Cleaning Validation
We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
31 related Medical device resources related to Medical Device Cleaning Validation
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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
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.
26 related Medical device resources related to Highly Accelerated Life Test
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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
Label Durability Validation
We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.
21 related Medical device resources related to Label Durability Validation
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- 2-4 week typical lead time
- Finished Product Testing
- Bulk Product/Batch Testing
- Life Cycle Testing
- Verification Testing
Whole Room Disinfection Systems Testing
We test a wide range of technologies including disinfection robots, fogging machines, electrostatic hand sprayers.
7 related Medical device resources related to Whole Room Disinfection Systems Testing
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- 4-5 week typical lead time
- EN17272:2020 – UKAS accredited
- Cycle development / range finder tests
- Distribution test
- Biocide monitoring / safety tests