We can advise on and plan for a wide range of regulatory compliance requirements pertaining to your project. This includes developing the regulatory compliance test plan, as well as managing the required testing with a suitable test house.

We've also implemented a Quality Program, at the heart of which is our Quality Management System (QMS), which is designed to meet the requirements of both ISO 9001:2015 and ISO 13485:2016 (Medical Devices).

Our Services

Compliance Support Services

  • Compliance program advisory services
  • Regulatory test plan development
  • Pre-Compliance and Compliance test program management
  • EMC and Electrical Safety compliance
  • Intrinsically Safe compliance
  • Medtech Device (hardware and software) compliance
  • Clinical Trial advisory services

Regulatory Expertise

  • Designing electrical and electronic systems that comply with mandatory regulatory requirements
  • Pre-compliance (pre-production) design reviews
  • Regulatory Compliance (design certification)

Regulatory Regime Experience

Electrical Safety

  • AS/NZS 3100 - General requirements for electrical equipment
  • AS/NZS 60950.1 - General requirements for Information technology equipment - Safety
  • AS/NZS 60598 - Electrical safety requirements for Household Lighting
  • AS/NZS 60745 - Electrical safety requirements for Handheld Power Tools

EMC and Radio Communications

  • CISPR 32 - Electromagnetic Compatability and Radiocommunications
  • IEC 60601-1-2 - Electromagnetic Compatibility (EMC)
  • AS.NZS 4268:20172 - Radio equipment and systems - Short range devices

Controlled Environments

  • IEC 60601-1 - Medical device electrical performance and safety
  • AS/NZS 2380.1-1989 - General requirements for electrical equipment for explosive atmospheres
  • AS/NZS 4118.1.4 - Fire Sprinkler Systems, Components - Valve Monitors

Environment and Waste

  • RoHS - Directive 2002/95/EC for the Restriction of Hazardous Substances
  • RoHS 3 - Directive 2015/863/EC including REACH listed Substances of Very High Concern
  • WEEE - Directive 2002/96/EC for management of Waste from Electrical and Electronic Equipment