Events

04.10.202316.00-18.00

04.10.2023

Introduction of medical devices into circulation for legal sale

11.08.202311.00-15.00

11.08.2023

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

13.07.202311.00-14.00

13.07.2023

Informing about changes to the conformity assessment body

20.06.202311.00-15.00

20.06.2023

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

26.05.202311.00-12.00

26.05.2023

The practice of remote audits of manufacturers under martial law

28.04.202310.00-14.00

28.04.2023

Regulatory requirements for the introduction into circulation of medical devices of risk class 1

31.03.202310.00-12.00

31.03.2023

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

03.03.2023

Recognition of EU certificates for medical devices. Actual questions and answers.

03.11.202211.00-15.00

03.11.2022

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

21.10.202211.00-15.00

21.10.2022

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

16.09.202211.00-15.00

16.09.2022

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

21.07.202211.00-15.00

21.07.2022

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

16.06.202210.00-14.00

16.06.2022

Development and implementation of a quality management system ISO 9001

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.

16.12.202110.00-14.00

16.12.2021

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

02.12.202110.00-14.00

02.12.2021

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

07.10.202115.00-17.00

07.10.2021

Certification of medical device manufacturing by pharmaceutical companies

07.10.202110.30-12.00

07.10.2021

Regulatory requirements for medical devices in laboratory practice

Introduction of medical devices into circulation for legal sale

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

Informing about changes to the conformity assessment body

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

The practice of remote audits of manufacturers under martial law

Regulatory requirements for the introduction into circulation of medical devices of risk class 1

Requirements and rules for placing medical devices on the market, including in vitro, for legal implementation

Recognition of EU certificates for medical devices. Actual questions and answers.

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

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

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

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

Development and implementation of a quality management system ISO 9001

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

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

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

Certification of medical device manufacturing by pharmaceutical companies

Regulatory requirements for medical devices in laboratory practice

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