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MEDICAL DEVICES


Article 33 and Article 30 of the new MDR (EU regulation 2017/745 and 2017/746) are the main articles requiring the establishment, maintenance and management of the European Database (Eudamed). This database is an indispensable element for the implementation of the new regulations, allowing, among other things, the traceability of the devices and better protection of health thanks to proactive market surveillance.

Normally companies use software to internally manage the data that is then transmitted to the database; these software must be validated as required by ISO 13485:2016 in paragraph 4.1.6. The expectations of notified bodies is that this validation is carried out in accordance with ISO TR 80002 2.

Adeodata is at the forefront in supporting its customers in valuating the opportunity of the ISO approach compared to GAMP 5, which remains theoretically applicable but often too expensive for the type of device produced.

All the consulting activities that Adeodata provides to the Medical Device industry:

- Validation of computerized systems (CSV)

- Qualification of process equipment

- Qualification of departments with controlled contamination and thermal mapping

- Instrument calibration

Adeodata S.r.l.
Via E. Mattei, 2

22070 Bregnano (CO)

 

 

Registered office: Via Carducci, 32 — 20123 Milano

VAT Nr. 05617310965    REA 1834791 Milano   PEC adeodata@pec.it

Adeodata SA
Via Calgari, 2

CH 6900 Lugano

IDI CHE-112.203.579

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