Services available for Foetal & Maternal monitors
![Clinical Evaluation](https://testlabsuk.com/app/uploads/2023/08/552-technicians-talking.jpg)
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
![Medical Device Biocompatibility Testing](https://testlabsuk.com/app/uploads/2023/09/Medical-Device-Biocompatibility-Testing-1.jpg)
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
- 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](https://testlabsuk.com/app/uploads/2023/09/Medical-Device-Biocompatibility-Testing.jpg)
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
![Pre-compliance IEC 60601-1 Testing](https://testlabsuk.com/app/uploads/2023/09/Pre-compliance-IEC-60601-1-Testing.jpg)
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 Cleaning Validation](https://testlabsuk.com/app/uploads/2023/09/552-two-technicians.jpg)
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
![Highly Accelerated Life Test](https://testlabsuk.com/app/uploads/2023/09/552-halt.jpg)
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
![Label Durability Validation](https://testlabsuk.com/app/uploads/2023/09/552-man-labeling.jpg)
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
![Medical Device Biological Evaluation Plan](https://testlabsuk.com/app/uploads/2024/01/evaluation-plan.jpg)
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.
- 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
- Completed by in-house toxicologist (competent person)
![Medical Device Biological Evaluation Report](https://testlabsuk.com/app/uploads/2024/04/Medical-Device-Biological-Evaluation-Report.jpg)
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.
- 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)
![ISO 10993-5 Cytotoxicity Testing](https://testlabsuk.com/app/uploads/2024/07/cytotoxicity-thumbnail.jpg)
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.
- 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
![ISO 10993-23 Test for Irritation](https://testlabsuk.com/app/uploads/2024/07/skin-irritation-thumbnail.jpg)
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.
- 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