🇨🇿 How to get prepared for the inspection of SÚKL

The event is held in Czech language only!

The webinar will offer a comprehensive overview of all phases of the inspection performed by SÚKL – from its announcement to the issuance of the inspection report, as well as the possible consequences, including subsequent administrative proceedings for offenses. The program will include an analysis of the most common shortcomings, ways to prevent them, and proper communication with SÚKL. We will also cover specific situations, such as inspections during holidays, deadlines for responding to inspection findings, and methods of rectification.

We will introduce you to the differences in inspections at various entities, including healthcare providers and custom device manufacturers. Practical advice and recommended preventive measures to minimize the risk of sanctions will also be an integral part of the webinar.

Who the webinar is for:

• manufacturers of medical devices

• manufacturers of custom-made devices

• importers of medical devices and IVDs

• distributors of medical devices and IVDs

• healthcare providers

• procedure packs producers

• service organizations

• anyone working in healthcare who wants to broaden their horizons by learning the basics of this issue

Speakers:

• Jakub Král

• Aneta Dostálová

Content:

• phases of SÚKL inspection and the follow-up procedures

• types of documents required and responses to requests for them

• differences in approach to individual types of entities

• most common deficiencies, inspection protocol, and report on the elimination of identified deficiencies

• administrative proceedings and offenses – what they mean and when they may follow

• practical examples – communication, deadlines, defense options

• differences between various types of inspections in the area of health insurance

• specifics of custom-made medical devices

Further information:

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

• 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 organized by:

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

  IČ: 17491681, DIČ: CZ17491681

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