We don't just do it,
we do it well.

We are experts in European medical regulations and provide consulting for CE marking of medical devices.

Company

Since 2011, we have been managing CE marking processes for medical devices of all classes, active and non-active. We mainly deal with electromedical devices, software, implantables, surgical instruments, and medical gas production and distribution systems.

Services

European Medical Device Regulation Consulting

We offer consulting to EU and non-EU manufacturers, authorized representatives, importers, and distributors of medical devices to ensure compliance with European regulations (MDR) for the legal placement of products on the market.

CE Marking for Medical Devices

We assist manufacturers in planning, managing, and completing the conformity assessment process for European regulations to obtain CE marking for medical devices.

ISO 13485 and MDSAP Quality System

We develop and implement quality management systems according to ISO 13485 for manufacturers, authorized representatives, importers, distributors, and other organizations involved in managing medical devices. We implement MDSAP requirements for manufacturers interested in non-EU markets involved.

Technical Documentation

We prepare technical documentation for CE marking of medical devices and commercial and industrial products according to the Medical Device Regulation (MDR), Machinery Directive (MD), Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), and Radio Equipment Directive (RED).

UDI and Eudamed Registration

We manage the acquisition and implementation of the UDI code and the validation of the printing process. We obtain the SRN for economic operators and register medical devices in the Ministry of Health database and in Eudamed, also providing solutions for bulk uploading.

Training Courses

We provide customized training courses, remotely or in-person, on European regulations in the medical device sector.

Work Method

At least two people for each project and a well-thought-out, repeatable work method

For each project, we define a work group with the necessary skills to ensure the management of various activities in parallel, reducing time and resources required from the client.

Our work method includes an exit strategy, updated infrastructure, flexibility, and the ability to constantly supervise the progress of work.