Services available for Instructions For Use
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
- BS EN ISO 17664-1:2021
- ANSI/AAMI ST98/ISO 15883-5
- ASTM F3208-20
Medical Device Reprocessing Validation
We validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.
- 4-8 week typical lead time
- Custom test rigs
- Bespoke testing setups
- Cleaning, Disinfection & Sterilisation cycles
- AAMI TIR30 / ANSI/AAMI ST98:2022
Medical Device Reprocessing Instructions Development
We develop cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.
- 2-4 week typical lead time
- Cleaning, Disinfection & Sterilisation
- IFU Development
- BS EN ISO 17664-1:2021
- ANSI/AAMI ST98/ISO 15883-5
R&D Medical Device Testing Support
Whether you’re refining a prototype, investigating a failure mode, or pushing the limits of what your device can do, we’re here to provide the technical testing support you need.
- 4-8 week typical lead time
- Custom test rigs
- Bespoke testing setups
- Proof-of-concept testing
- Cross-disciplinary support
Medical Device Sterilisation Validation
We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.
- 4-5 week typical lead time
- Simulated use/accumulation study
- BS EN ISO 17664-1:2021
- ISO 14937:2009
- BS EN ISO 17665:2024
Medical Device Disinfection Validation
We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.
- 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
Reprocessing Validation for Class 1r Medical Devices
We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.
- 4-week typical lead time
- BS EN ISO 15883-5:2021
- BS EN ISO 15883-2:2009
- BS EN ISO 17665-1:2006
- 17025 UKAS accredited
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