Service Details
CE Marking for Medical Devices
We assist manufacturers in planning, managing, and completing the conformity assessment process for European regulations to obtain CE marking for medical devices.
Context and Introduction
Completing the conformity assessment process for a medical device according to Regulation (EU) 2017/745 determines the applicability of CE marking, which allows for market placement and free circulation within the European Union.
01
Quality System
We develop and implement quality management systems according to ISO 13485 for manufacturers, authorized representatives, importers, distributors, and other organizations involved in managing medical devices. We implement MDSAP requirements for manufacturers interested in non-EU markets involved.
02
Technical Documentation
We prepare technical documentation in compliance with Annex II of Regulation (EU) 2017/745 (MDR), as part of the conformity assessment process for Class I, Class I sterile, measuring function, reusable, Class IIa, IIb, and III medical devices.
03
UDI and Registration
We manage the acquisition and implementation of UDI codes and validate the printing process. We obtain SRN for economic operators and register medical devices in the Ministry of Health database and Eudamed, also providing solutions for bulk uploading.
04
Labeling and Implant Card
We develop labeling projects and manage readability and indelibility tests. For implantable device manufacturers, we provide the implant card and printing system compliant with regulatory requirements.
Contact Us
Needs Analysis
Use the contact details in the contacts section: we can provide more details, arrange an introductory meeting, structure a tailored service, and define a dedicated economic offer.
