Regulatory Compliance

Category:

 

ISO 9001 Quality management system is a must today that will command respect and diffusion world wide.

 

ISO 140001 Environmental Quality Management is an obligation for companies operating in the wide world of ecosystem.

 

ISO 60601 Medical electrical equipment norms are essential to establish the security of the devices as far as electrical circuits is concerned

 

FDA This is the USA path to get approval for use in the USA

 

ISO 10993 is essential for the biological medical security to ensure that no harm can attain the users of the products

ISO 13485 specifies a quality management system requirements that demonstrate a company’s ability to provide medical devices and related services that consistently meet the legal requirements applicable to medical devices and related services in terms of customer needs.

MDD 93/42/EEC This is the European path to get approval for use in Europe. Other norms are available for air filtration in clean rooms or water filtration in water. The list is long, but we will reproduce products that are compliant to all these norms.