Events

21.10.202211.00-15.00
21.10.2022

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

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27.10.202211.00-15.00
27.10.2022

Conformity assessment for I class medical devices and some devices for IVD. Technical file structure.

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03.11.202211.00-15.00
03.11.2022

Relevance of medical device conformity assessment through EC-certificates recognition during martial law

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16.09.202211.00-15.00
16.09.2022

Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

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21.07.202211.00-15.00
21.07.2022

Technical regulations for cosmetic products. Production certification according to EN ISO 22716:2007.

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30.06.202211.00-14.00
30.06.2022

Information about changes. Evaluation of changes by the conformity assessment body.

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16.06.202210.00-14.00
16.06.2022

Development and implementation of a quality management system ISO 9001

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17.02.202210.00-14.00
17.02.2022

The main provisions of the principles of HACCP. The practice of developing and implementing the principles of HACCP at the enterprise.

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16.12.202110.00-14.00
16.12.2021

The most important regulatory changes in the medical device industry. Digest 2021.

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02.12.202110.00-14.00
02.12.2021

Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

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07.10.202115.00-17.00
07.10.2021

Certification of medical device manufacturing by pharmaceutical companies

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07.10.202110.30-12.00
07.10.2021

Regulatory requirements for medical devices in laboratory practice

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