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.
We help ensure manufacturers, distributors, importers and authorised representatives 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 quality systems 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 technical files 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, authorised representatives 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.
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.
Insights and news from the medical device industry and our company
The guideline MDCG 2022-08, issued in August 2022, raised an alarm about the possibility of shortages of medical devices due to the complexity of implementing
Services
Sistemir EU S.r.l.
Lecco, LC 23900
Via Ponte Alimasco, 13
segreteria@sistemir.com
+39 0341 1716381
VAT n. 03924150133
Administrative index no. LC-407096
Share capital € 10,000.00 fully paid
Copyright © 2022 Sistemir EU S.r.l. All rights reserved.
