ISO 13485 Professional Training

Medical devices quality management system training course

• 

  ISO 13485:2016 Outline

  Medical devices have a direct impact on human life and health, so they need to guarantee a higher level of stability than any other product. Therefore, the medical device industry has a variety of regulations that must be met, including domestic regulatory systems, international standards and other requirements.
  
  ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations providing medical device design and development, production, installation and additional services.
  
  In addition, this standard can be applied to external organizations that provide services such as sterilization, calibration, and sales to medical device organizations, providing the basis for a quality management system to organizations that provide medical devices and related services.

• 

  The importance of ISO 13485 training

  Medical devices have a direct impact on human life and health, so they need to guarantee a higher level of stability than any other product.
  
  For the effective application of the standard ISO 13485, companies and industries need qualified professionals. The purpose of the ISO 13485 Auditor Certification process is to provide the certification body with the confidence that auditors and individuals certified through this program are eligible.
  
  As part of the certification process, assessments will be conducted against requirements that reflect the core skills, knowledge and experience that define eligibility. The ISO 13485 training program is based on the ISO 13485 standard, and is based on the audit guidance standard ISO 19011:2018.