Standards Compliance:

Regulatory EMC, Safety & Risk Management

Genesys has extensive experience in the design of products for compliance with regulatory standards. We design for regulatory compliance; it is not an after-thought in our process, and this is one of the pillars of our One Pass To Production™ guarantee. All designs allow full production test coverage to meet requirements such as SIL and IEC60335-1.

We can also assist you in determining product regulatory compliance labeling requirements, and with the preparation of installation manuals where these are required in support of regulatory compliance testing and inspection. We can also assist with subcontract manufacture selection, as well as PCB and component sourcing for safety-critical aspects of the design.

Compliance Engineering

Genesys follows a disciplined standards based approach to product development. During the first steps of our development process we conduct extensive standards analysis to identify and understand the implications of standards requirements for a product’s design. We then use this information to develop products that are compliant from the outset.

Genesys works with an extensive network of local and international test laboratories and compliance bodies to verify and approve products. We can manage the entire compliance process.

Genesys has extensive experience with Australian and international EMC, Safety, Biomedical, and product specific standards. We also possesses an extensive standards library.

Genesys conducts independent reviews of 3rd party designs aimed at identifying compliance issues. We also test, analyse and correct non-compliant 3rd party designs.

Standards Compliance: regulatory EMC, safety & risk management

Standards Compliance: regulatory EMC, safety & risk management - among other considerations.

Other Genesys Services:

Certification Management

Genesys can manage the process of certifying your product in accordance with applicable Australian and international standards.

This includes:

  • Working with our clients to identify applicable standards and plan the compliance and certification process.
  • Analysing and assessing standards to determine key requirements affecting a product’s design & labeling.
  • Reviewing 3rd party designs to identify compliance issues.
  • Undertaking design remediation activities to correct compliance issues.
  • Preparing information packages for briefing laboratories in support of compliance inspection and testing.
  • Identifying suitable test laboratories and obtaining competitive quotations.
  • Setting up products and systems in support of compliance testing.
  • Managing and assisting with pre-compliance testing, and formal compliance testing.
  • Interpreting and assessing compliance reports.

Regulatory Standards

As well as being ISO 13485:2016 certified, we are also fully conversant with the standards below.

When we encounter a regulatory standard such as product-specify standard which we have not previously applied, we review the requirement of the standard as they affect your product’s design, and incorporate these requirements in the product specification.

Mains Safety
  • AS3000
  • AS3100
  • IEC 60730-1
  • IEC 60335-1
  • AS/NZS 61558 (transformers)
  • UL60950
Product & Software Safety
  • IEC 60601-1
  • IEC 60730
  • IEC 60335
  • IEC 62304
  • MISRA
  • UL924
Medical
  • ISO 13485:2016 certified (MD647437) (quality)
  • ISO 14971 (risk management)
  • IEC 60601-1 (product)
  • IEC 62304 (software)
Aerospace & Military
  • RTCA DO-160
  • RTCA DO-178
  • RTCA DO-254
  • MIL-STD-810
Materials Safety
  • RoHS
  • WEEE
EMC Emissions (C-Tick, CE, FCC)
  • CISPR11 (ISM)
  • CISPR12 (vehicles)
  • CISPR14 (household)
  • CISPR22 (IT)
  • EN61000-1 (general)
  • EN61000-2-1 (conducted)
  • EN61000-2-3 (radiated)
  • EN61000-3-2 (harmonics)
  • EN61000-3-5 (flicker)
ESD
  • EN61000-4-2 ESD
EMC Immunity (CE and Safety Critical)
  • EN61000-4-3 (radiated)
  • EN61000-4-4 (transient)
  • EN61000-4-5 (surge)
  • EN61000-4-6 (conducted)
  • EN61000-4-7 (harmonics)
  • EN61000-4-8 (magnetic)
  • EN61000-4-9 (pulse)
  • EN61000-4-11 (dips)
Hazardous Areas & Ingress Protection
  • IPxx
  • Intrinsic Safety
  • Safety Integrity Level (SIL)