ISO 13485

Topdental has certification ISO 13485 that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It is tailored to the industry’s quality system expectations and regulatory requirements. Our ISO 13485 certification shows amonst others that we:

  • Have established a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services.
  • Have demonstrated the ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.
  • Have evaluated how our organization is able to meet customer expectations and comply with regulatory requirements.

ISO 13485 is not a product standard. It’s a process standard.
Therefore we also comply with all relevant product and service oriented technical standards and regulations.

CE Marking

All our products are CE marked to the required standard up to Class llb Medical devices. The CE mark is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. We are audited each year by our notified body to ensure the scrict guidelines are adhered to.