Sistemir.
Not only we do it.
We do it well.

Experts in European medical regulation, providing consultancy on CE marking for medical devices.

Company

Sistemir was established in 2011 after founding partner Fabio Valtorta had spent 25 years working in the medical industry. These days we are a well-structured company, with a mix of youth and experience; we manage the CE marking process for all classes of active and non-active medical devices. We dealing mainly with electromedical and implantable devices, software and surgical instruments.

Services

We help ensure manufacturers, distributors and importers comply with the regulation applicable to medical devices (MDR, harmonised standards and national legislation). Specifically, we set out strategies and guidelines for CE marking, market entry, and after-sales management.

We provide consultancy on MDR-compliant CE marking for new medical devices and approval for modifications to products with existing markings. We also manage the relationship with notified bodies.

We develop a quality system based on ISO 13485 for companies that manage medical devices, which also ensures conformity with the 2017/745 medical device regulation (MDR). In addition, we provide on-site support for certification and monitoring audit from the competent authority.

We develop the technical file for CE marking of medical devices and commercial products based on the 2017/745 medical device regulation (MDR), or the machinery, low voltage, and electromagnetic compatibility directives.

We manage the registration of manufacturers, importers, distributors and medical devices on to the Eudamed database. We also secure and support the use of the UDI code (UDI-DI, UDI-PI and basic UDI).

We deliver approved training courses on European and Italian regulation in the medical devices industry.

How we work

At least two team members on every project and working methods tailored to individual clients.

For every project we assemble multi-person teams with the right expertise. This allows us to manage a range of activities in parallel, reducing the time and resources asked of the manufacturer.

In terms of specifics, we guarantee an exit strategy, updated infrastruture, flexibility, and the opportunity to continually monitor progress.

UNI@2x
Gilardoni@2x
Fondazione-Don-Gnocchi@2x
Tecno-Gaz@2x

Blog

Updates from the medical devices industry and our company.

Scansione codice UDI registrato in Eudamed

Registrare i codici UDI in Eudamed

In seguito all’ultimo aggiornamento di Eudamed è possibile registrare i codici UDI. I prodotti da registrare, a cui i codici si riferiscono, sono: i dispositivi

Copertina della gazzetta ufficiale contenente le norme armonizzate all'MDR

MDR: l’elenco delle (poche) norme armonizzate

Il punto di partenza per la scelta delle norme da applicare ad un prodotto, è l’analisi dell’OJEU, la Gazzetta Ufficiale dell’Unione Europea. Nell’ambito della Direttiva