Rafimed operates clean rooms Class 7 (10,000) and has an external quality inspector ISO-13485 standard.

The work process in the clean rooms includes tests (air quality, stable temperature, etc) on a daily basis. We maintain controlled level of particles per cubic meter, and conduct quality control according to the regulation.

The company QA manager, as well as the manufacture team, has years of experience in a clean environment. The maintenance and the work in the clean rooms, is done according to ISO-14644 standard.

Among the solutions offered by Rafimed:

  • Product manufacturing inside& outside of clean rooms: assembly, cleaning, sanitization and packaging.

  • Using the company clean rooms for development and assembling a prototype.

  • Small batch specialized assemblies for testing.

  • The company specialized in manufacturing of implants, catheters, intrauterine device, and valves, and has also the ability to produce paramedical devices.

 

Tell us what is your challenge, and we will help you to achieve it.