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.
CE marking ensures that safe products can circulate freely within the European Union. Specifically, the manufacturer must develop and maintain an updated technical file on the product to document its compliance with general safety and performance requirements as defined by regulations or guidelines.
We develop technical files for the certification of class I and class I sterile medical devices (electromedical and non-electromedical), including those with measuring functions and those that are reusable, as well as class IIa, IIb and III devices; based on the 2017/745 medical device regulation (MDR) and harmonised standards.
We develop technical files for the certification of commercial products complying with the low voltage (2014/35/EU), electromagnetic compatibility (2014/30/EU), and machinery (2006/42/EC) directives.
We can develop single documents: EN 14971 risk management, clinical evaluation, EN 60601-1-6 and EN 62366 usability file and EN 62304 software compliance. These can also be used to supplement pre-existing technical files. These can also be used to supplement pre-existing technical files.
We set out the impact of modifications to the product and the process, and the best strategy to manage them. We also adapt the documentation and deal with the approval of the technical file from the notified body.
We have the technical experience required to manage relationships with any testing laboratories and notified bodies. We deal with them directly and manage requests for proposals, the planning stages, and launching operations
Use the details in the contact section to get in touch: we can give you more information, organise an initial meeting, create a bespoke service, or put together a dedicated quote.
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.
