Services available for Single use instruments
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
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
Medical Device Bioburden Testing
Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.
- 3-4 week typical lead time
- TYMC “Total yeast mould count”
- TAMC “Total aerobic count”
- Specific pathogen testing
- ISO 11737 & ISO 11137 sterilisation method validation
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 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 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
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
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
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