Medical Equipment:

Regulatory Compliance

Genesys has detailed knowledge and depth of expertise in medical equipment regulatory compliance requirements, in particular electrical safety/isolation; and equipment functional safety/risk management, such as:

  • IEC 60601-1
  • ISO 14971 (risk management)

We can lead or assist with the preparation of all types of documentation required in support of the medical equipment regulatory compliance process.

We have a comprehensive manual which identifies and describes the documentation required for medical equipment compliance.

Other Genesys Consulting Services:

Looking for design or development servivces? Genesys Electronics Design provides a complete electronic product and software development service from initial concept through to volume production: www.genesysdesign.com.au.