ISO 13485 Quality Management System for Medical Devices
ISO 13485 Quality Management System for Medical Devices

Target Audience

The Standard can be applied by Organizations involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, repair and provision of corresponding activities (eg. technical support). ISO 13485 can also be used by suppliers or external parties that provide medical devices. The requirements of ISO 13485 Standard are applicable to Organizations, regardless of their size and type

The Benefits:

The implementation and certification against ISO 13485 Standard has advantages such as:

  • Safe Products
  • Meeting legislative requirements
  • Improved quality of services / products
  • Satisfied customers
  • Better management control

Certification Process / Required Documents

The Organization interested to achieve certification against ISO 13485 Standard requirements contacts BQC and fills in the certification application.

An initial audit is conducted and if successful, a certificate of compliance is issued that is valid for 3 years, provided that the organization undergoes an annual audit.

Why choose BQC

The Certificates issued by BQC are internationally recognized. BQC cooperates with experienced inspectors and experts from all over the world, ensuring the most updated and professional knowledge in any business sector.