ISO 13485

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that meet customer and applicable regulatory requirements. It can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Who should use the ISO 13485?

ISO 13485 is applicable to organizations regardless of their size or their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

Our Services

We can help you achieve ISO 13485 certification by:

  • Conducting gap analysis (review the your regulatory strategy)
  • Developing QMS Manual
  • Developing 13485 processes / policies / forms and templates
  • Training

Our approach

It takes us about 3 to 5 weeks to complete the process.

Do you want to know more about our Services? Come meet us and we’ll discuss any worries you may have:
Schedule an appointment.