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.
Introducing an ISO 13485-based quality management system is an essential pre-requisite to securing CE marking for medical devices. It also enables suppliers, importers, distributors and authorised representatives to follow current regulations correctly.
No less important, it also gives management a clear view of internal processes, making it easier to see how they are related and identify strengths and areas for improvement.
Our starting point is a documentation structure that is subject to constant monitoring, which guarantees that standards and regulations are respected. Meanwhile, those parts of the system connected to operations are specially created and documented to ensure they accurately reflect company processes.
We know how to support clients in defining and managing work flows and the tools that are needed. We have particular experience of production processes, cleaning, managing controlled contamination environments, and sterilisation. We have particular experience of production processes, cleaning, managing controlled contamination environments, and sterilization.
We provide on-site support for certification and monitoring auditing. We have the technical experience required to manage the relationship with the certifying and notified bodies, from the request for proposal through to the planning stages and launching operations.
We carry out inspection and monitoring audits of suppliers and out-sourcers, and develop technical agreements that ensure conformity to regulatory guidelines and standards.
We can maintain your quality system on a long-term basis, or provide training to staff throughout each phase, giving you complete autonomy going forward.
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
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