Compliance & certifications
Compliance documented, model by model
Our devices are intended for professional use by trained operators. For each model we provide customers with the applicable regulatory documents before any order.
CE marking
CE marking attests that the device meets the applicable European requirements (electrical safety, electromagnetic compatibility, laser safety and, where relevant, medical-device requirements). Each model comes with its declaration of conformity.
ISO 13485 — quality
Quality-management standard specific to medical devices. It applies to the production site: controlled design, component traceability, inspection of every device before shipping.
Regulation (EU) 2017/745
The MDR governs medical devices placed on the European market. Depending on its intended purpose, a device falls under the MDR as a medical device or under Annex XVI as a product without a medical purpose. The status of each model and its technical file are provided on request.
Request a model’s documentation
Tell us the model and destination country: we will send the declaration of conformity, certificates and data sheet.