STANDARDS & INSURANCE

Product Liability Insurance

Medisafe has comprehensive Product Liability Insurance that covers all repairs, testing and calibration.

*Please note: Do not confuse Product Liability with Public Liability. Public Liability Insurance does not cover Engineers for invasive work on medical equipment. For example, Public Liability Insurance does not cover basic repairs or the simplest of tasks such as replacement of a battery.

ISO 9001 CERTIFIED

ISO certification is an international recognised to meeting the standards that are important to industry. It is a commitment to those standards which are audited annually that can be trusted by potential customers, and existing customers.

The ISO 9001:2015 Quality Management System specifies what your organisation needs to do:

  • To provide products and services that consistently meet customers’ needs
  • To enhance customer satisfaction through a processes of continual improvement
  • To ensure it conforms with all applicable statutory and regulatory requirements

ISO 9001 is the ultimate global benchmark for quality management and a critical tool for business.

IEC60101-1

Electrical safety is a crucial part of the safety validation testing of medical electronic devices and requires specialised test equipment and electrical safety analysers that test the medical equipment in accordance with IEC 60601-1.

Research shows that current, not voltage is often the source of injury or death, so testing to the standards of IEC 60601-1 is imperative to control the safety of medical devices.