Quality Management, Certifications and reliable safety are our top priorities. Our products are developed, manufactured, and tested in accordance with international standards. The following certificates demonstrate our compliance with the highest quality, safety, and management standards across all areas of production and development.
- EC Certificate / Directive 93/42/EEC [>> pdf]
- Notified Body Confirmation Letter [>>pdf]
- Lettre de confirmation de l’organisme notifié [>>pdf]
- Manufacturer’s Declaration [>>pdf]
- MDSAP [>>pdf]
- CeramOptec GmbH: ISO 9001:2015 [>> pdf] (French version: ISO 9001:2015 [>> pdf])
- CeramOptec GmbH: EN ISO 13485:2016 [>> pdf] (French version: EN ISO 13485:2016 [>> pdf])
- Ceram Optec SIA: ISO 9001:2015 [>> pdf]
- Ceram Optec SIA: EN ISO 13485:2016 [>> pdf]
- Ceram Optec SIA: ISO 14001:2015 [>> pdf]
- Ceram Optec SIA: EN ISO 11135:2014 [>> pdf]
Device Identification, Safety and Performance Information Brochures
