Home Healthcare Equipment Testing and Certification

Testing and Certification to the Home Healthcare Standard IEC 60601-1-11

Requirements for Home Healthcare have an increasing role in the medical devices industry, especially in a post-COVID19 environment. Meet industry requirements on schedule with a partner who provides regulatory consulting to help guide you through the compliance requirements for your device. We can test your medical electrical equipment to the basic safety and essential performance requirements of the new collateral standard for home healthcare, including all standard deviations for the U.S., Canada, and Europe. To get started, download our Home Healthcare Checklist (Excel).

 

Medical Electrical Equipment for the Home Healthcare Environment
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*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.

 

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