ISO 13485 from e-certifications
e-certifications ISO 13485

ISO 13485:2016(Medical devices-QMS)

ISO 13485 (Medical devices-QMS) is an international standard to be used by organizations which are involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, it covers all the aspects of quality management in Medical equipment industry

Benefits Of ISO 13485

  • Complete and sound product requirements
  • Defined protocols to be followed for risk analysis and risk control
  • Customer centered approach for the product development
  • Promotes and enhances the reputation of the brand
  • Quality assurance

Why should I get ISO 13485?

Being an International standard for Quality Management Systems in the medical device industry,ISO 13485 this is tested and proven that this complies with two different standards (ISO 9001 & medical industry specification), same ways it gives double benefits.It's proof of quality assurance and its best used for promotion of the brand