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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 used to populate the database; these software must be validated as required by ISO 13485:2016 in paragraph 4.1.6. ISO 13485:2016 in paragraphs 7.5.6 and 7.6 also require, respectively, the validation of the software applications used in the production and service delivery processes and for the monitoring and measurement of requirements.

The expectation of notifying entities is that this validation is carried out in accordance with ISO TR 80002 2.

This approach also meets the expectations of the FDA expressed in 21 CFR part 820.70 (i) and in chapter 6 of the "General principles of SW validation" guideline. In fact, FDA also requires that the computerized systems used in the production or quality system of a medical device manufacturer be validated with respect to their intended use.

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

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