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.
Not complying with the regulation applicable to medical devices can result in serious legal sanctions.
That’s why, in a continually evolving industry, it’s crucial to draw up a planning, production, certification, sales, and after-sales management strategy alongside constant support that ensures full conformity with the current requirements.
We classify the medical device, establish the best strategy for CE marking, provide realistic timeframes to obtain marking, and set out an approach to complying with the applicable legislation standards.
We manage the entire MDR-based CE marking process for new devices, as well as approval for modifications to products with existing markings. We also look after the relationship with notified bodies.
To help manufacturers, distributors, importers and authorised representatives to respect current regulation, we set out the requirements applicable in the nations where the medical devices are sold (including non-EU countries) and provide consultancy to comply with them.
We monitor the market for updated standards, look at scientific literature and seek out negative outcomes involving similar medical devices in international databases. On completion, we support clients in managing incidents, non-conformity, complaints, and recalls.
We set out the impact of modifications to the product and the process, and the best strategy to manage them. We also manage adapting documentation and approval from the notified body.
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.
