ISO 13485


ISO 13485 - Quality Management Standard


ISO 13485 Certificate specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.


What do you need?

  • Learn about Risk Management in Medical Devices?
  • Compare ISO 9001 & ISO 13485?
  • To create an ISO 13485 Quality Manual, Procedures & Forms?
  • An easy way to implement ISO 13485?
  • Help planning and executing your project?
  • Help Creating an Internal Audit Program?
  • To train your Employees?
Requirements of ISO 13485
  • A manufacturer must have quality procedures compliant to ISO 13485 that are documented, controlled, and effectively implemented and maintained.
  • A manufacturer must ensure that its personnel have the right experience, education, training, and skills.
  • A manufacturer must plan how remedial processes will be used to assure conformity.
  • An easy way to implement ISO 13485?
  • A manufacturer must plan and perform regular internal audits.