23.10.2020
Do all medical devices have to be certified?
Do all medical devices have to be certified The subject of certification of medical devices regularly appears in the...
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21.03.2022
We are very pleased to inform you about the next extension of the scope of PCA accreditation in the program area PN-EN ISO 9001: 2015-10 and PN-EN ISO 13485: 2016-04 . In the case of QMS, the extension applies to code 33, ie Information Technology, while for MDMS, the extension applies to code 1.1 – Inactive medical devices – General inactive unimplanted medical devices. Our current scope of accreditation is available on the website Polish Center for Accreditation under link – scope . At the same time, meeting the expectations of our clients, we openly declare that at the turn of March and April we will start another process of extending the scope of accreditation with new MDMS codes – ISO 13485. We sincerely hope that you will see the effects of these activities in the third quarter of this year.
NewsDirector of the Sales and Marketing Department
CeCert Sp z o. o.