Events

26.04.202411.00-15.00
26.04.2024

Quality management system at enterprises designing, developing, producing and selling medical products. General information.

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10.05.202411.00-15.00
10.05.2024

Conducting internal audits in accordance with the provisions of DSTU ISO 19011:2019

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24.05.202411.00-15.00
24.05.2024

Formation of a technical file for medical devices

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07.06.202411.00-15.00
07.06.2024

Quality management system at enterprises importing and selling medical devices. General information.

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12.04.202411.00-15.00
12.04.2024

Communication and interaction with State Service of Ukraine on Medicines and Drugs Control and conformity assessment bodies

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29.03.202411.00-15.00
29.03.2024

Organization of contract manufacturing OBL-OEM in terms of technical regulation

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01.03.202415.00-17.00
01.03.2024

Post-marketing surveillance. A framework for studying, analyzing and preventing adverse events associated with medical devices on the market.

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16.02.202411.00-15.00
16.02.2024

Risk management, the basis of integrated management

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02.02.202411.00-15.00
02.02.2024

Legislation of Ukraine in the field of technical regulation of medical devices

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22.12.202311.00-15.00
22.12.2023

Quality management system at enterprises importing and selling medical devices. General information.

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15.12.202311.00-15.00
15.12.2023

Formation of a technical file for medical devices

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30.11.202311.00-15.00
30.11.2023

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

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24.11.202311.00-12.00
24.11.2023

The practice of remote audits of manufacturers under martial law

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08.11.202309.00-18.00
08.11.2023

Good manufacturing practice: overview of the principles and requirements of the DSTU EN ISO 22716 (GMP) standard

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03.11.202315.00-16.00
03.11.2023

Informing about changes to the conformity assessment body

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17.10.202311.00-12.00
17.10.2023

Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

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12.10.202312.00-12.30
12.10.2023

Requirements, implementation and certification of HACCP / ISO 22000 in the production of dietary supplements

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10.10.202318.00-18.30
10.10.2023

ISO 22716 (GMP) requirements for cosmetic manufacturers

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04.10.202316.00-18.00
04.10.2023

Introduction of medical devices into circulation for legal sale

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22.09.202311.00-12.00
22.09.2023

Recognition of CE certificates in 2023: extension of MDD certificates until the end of 2028, recognition of MDR

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21.09.202316.30-17.00
21.09.2023

Standard ISO 22716 “Cosmetics. Good Manufacturing Practice (GMP)”

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31.08.202313.50-14.10
31.08.2023

New MDR and ISO 13485 requirements for a distributor of a foreign manufacturer

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11.08.202311.00-15.00
11.08.2023

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

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13.07.202311.00-14.00
13.07.2023

Informing about changes to the conformity assessment body

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20.06.202311.00-15.00
20.06.2023

INTERNAL AUDITS | BASIC COURSE | ISO 19011 REQUIREMENTS

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26.05.202311.00-12.00
26.05.2023

The practice of remote audits of manufacturers under martial law

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28.04.202310.00-14.00
28.04.2023

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

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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

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03.03.2023
03.03.2023

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

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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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21.10.202211.00-15.00
21.10.2022

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

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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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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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