Services available for Magnetic Resonance Imaging
IEC 60601-1 Testing and Certification
We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series
- 4-6 week typical lead time
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- US-NRTL certification according to ANSI/AAMI ES60601- 1 and CAN/CSA-C22.2 No. 60601-1
- INMETRO certification for access to the Brazilian market
IEC 60601-1-2 EMC Testing
We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2
- 2-4 week typical lead time
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- IEC 60601-1-2:2020 (ed. 4.1) – Medical electrical
equipment - Review and verification of EMC test plans, risk analysis, and user manuals
Accelerated Aging Testing
We perform accelerated aging testing and real time
ageing studies to determine how a products behave
under normal storage/use conditions over long periods
of time.
- 3-4 week typical lead time
- ASTM F1980 Sterile Barrier Systems & Medical Devices
- ISO 11607 Packaging for terminally sterilized medical
devices
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
Extractables & Leachables (E&L) Testing
We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.
- 2-4 week typical lead time
- ISO 10993-18
- USP<1663>/<1664>, USP <665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Study Design
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
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