If you are looking for an effective way to monitor and manage the activities of your company, the best solution is to create and / or implement a Quality Management System. This will allow you to provide 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 meet the established requirements.

The use of internationally recognized standards such as ISO 9001 and ISO 13485 is a solid starting point for achieving your goals. In particular, 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 producers wishing to sell their devices in Europe, but almost all companies choose to apply it because, generally, it meets the requirements of the regulations and is considered suitable for the application of harmonized technical standards. In addition, it meets the system requirements required in many other countries such as Canada, Japan, Australia and many others.

  • Prepare, implement and maintain your Quality Management System in accordance with ISO 13485 and ISO 9001
  • Create your Quality Manual and define your Quality Policy
  • Take on the role of Quality Assurance for your company
  • Support you during Notified Bodies and Competent Authorities inspections
  • Check your, distributors, and/or contract manufacturers’ Quality Management Systems
  • Train your company from quality, regulatory and/or validations prospective
  • Prepare and implement your Standard Operating Procedures (SOPs)
  • Manage the non-conformities and CAPA (Corrective and preventive action)
  • Prepare, manage and monitor procedures concerning to Post-Market Surveillance (PMS)
  • Prepare data recording systems
The ISO 13485 integrates the ISO 9001 standard with which it shares several aspects. However, there are additional requirements related to process control, design, archiving of reports, distribution of responsibilities and traceability.