🇨🇿 Handling of medical devices and IVDs in hospitals - common mistakes and good practice

The event is held in Czech language only!

In this webinar, we will focus on good practice when handling medical devices in hospitals and other healthcare facilities. We will provide an overview of the main obligations of healthcare providers and highlight problematic areas of compliance. We will cover product legality control when purchasing devices, storage practices, mandatory instructions, servicing medical devices, documentation management, using devices, IFU management and vigilance issues. We will give our recommendations on how to fulfil these obligations in practice. We will also mention re-sterilisation, in-house manufacturing of devices and preparation for inspections by regulatory authorities. The programme is designed for all healthcare professionals who want to ensure that medical devices are handled correctly in accordance with legislation, while being as practical and efficient as possible.

Who the webinar is for:

• physicians and non-physician medical personnel handling medical devices

• persons responsible for the administration of public procurement and purchasing of devices

• medical technology department staff, biomedical engineers, service technicians and medical device maintenance specialists

• persons responsible for the storage and logistics of medical supplies

• managers and executives of medical establishments who wish to ensure effective process management in accordance with the legislation

• all those working in the healthcare sector who want to broaden their horizons with the basics of this subject

Lecturers:

• Aneta Dostálová

• Jakub Král

Content:

• legislative framework (european MDR and IVDR regulations, czech legislation)

• overview of the obligations of healthcare providers in relation to the MDR and IVD

• verification of legality when purchasing devices

• good storage practice

• instructions of users and service of devices

• documentation management on medical devices and IVDs, UDI issues, recording in the patient's medical documentation, implant cards

• management of instructions for use

• re-sterilisation of medical devices

• in-house devices

• control of SÚKL

• answers to questions from the practice

Additional information:

• during the webinar, participants will have the opportunity to ask questions

• each participant will receive a certificate of participation

• a PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica Legal s.r.o., advokátní kancelář

• ID: 17491681, VAT: CZ17491681

• registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město