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If you are looking for an effective way to control and manage the activities of your company, the best solution is to create a Quality Management System (QMS).

It is a collection of policies, processes, documented procedures and records that define the internal rules on how your company creates and supplies products and / or services. The QMS must be custom-made depending on what you want to provide.  

This will allow you to create products and / or services that meet the needs of your customers, address the risks and opportunities associated with the context of your business and demonstrate that the processes comply with the established requirements.

The use of internationally recognized standards such as ISO 9001 and ISO 13485 represents a solid starting point for achieving your goals.

ISO 13485 is a harmonized technical standard for quality systems issued specifically for companies involved in the production, storage and distribution of medical devices. The application of this standard is voluntary for manufacturers who wish to sell their devices in Europe, but almost all companies choose to apply it as it generally meets the requirements of the regulations and is considered suitable in the application of harmonized technical standards. In addition, it meets the system requirements required in many other countries such as Canada, Japan and Australia.

ISO 13485 complements ISO 9001 with which it shares several aspects. However, there are additional requirements for process control, design, archiving of reports, distribution of responsibilities and traceability.

ISO 9001 is the international standard for the QMS of any company. It can be used by organizations of any size or sector. As an international standard, it is recognized as the basis for creating a system that ensures customer satisfaction and improvement of any company and, therefore, many companies foresee it as a minimum requirement for their suppliers.


VISPE Medical Device Consulting, Quality section, can help you:
  • Prepare, implement and maintain your QMS in accordance with ISO 13485 and ISO 9001
  • Create the Quality Manual and define the Quality Policy
  • Support you during inspections of Notified Bodies and Competent Authorities
  • Check your quality management system and the one of your distributors and / or suppliers
  • Train your company from a qualitative, regulatory and/or validation point of view
  • Implement and prepare SOPs
  • Manage non-conformities and CAPAs
  • Prepare, manage and monitor procedures related to PMS
  • Prepare data recording systems

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