03.12.2021 /regulation 2017/745 /ivdr /MDR /Regulation 2017/746

CeCert on the way to MDR and IVDR

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CeCert on the way to MDR and IVDR

We are pleased to inform you that CeCert as an accredited entity in the scope of ISO 9001 and ISO 13485, as well as a future notified body in the scope of Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices accepts the challenge of submitting an application for notification under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR).

It is no secret that the greatest challenge for medical device certification bodies is to have competent personnel to assess and verify product documentation and the manufacturers’ quality management system, and finally to make decisions related to the issuance of a certificate. Therefore, we are starting an open recruitment for MDR and IVDR experts. If you have an education relevant to the product under assessment, e.g. medicine, pharmacy, laboratory diagnostics, engineering or other related sciences) and you have a minimum of four years of professional experience in the field of healthcare products or related activities, such as production, audit or research, two of which four years will be devoted to the design, manufacture, testing or use of a product or technology to be assessed or related to the scientific aspects to be assessed, please send your CV to our HR department -> kariera@cecert.pl

The work of the person assessing and / or verifying the documentation of a medical device is associated with the preparation of a report on the assessment of the effectiveness of a medical device and can be performed in any geolocation without the need to visit the manufacturer of the medical device. On the part of CeCert, we provide appropriate training and support of our experts.

Due to the international nature of CeCert’s operation, knowledge of the English language is welcome.

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