Services available for Electrical Safety

Medical Device Reprocessing Validation

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
R&D Medical Device Testing Support

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
IEC 60601-1-2 EMC Testing

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
IEC 60601-1 Testing and Certification

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
Highly Accelerated Life Test

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
Pre-compliance IEC 60601-1 Testing

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