🇨🇿 Basics of quality management system - ISO 13485 is not enough

The event is held in Czech language only!

In this seminar, we will provide valuable practical information for all those responsible for preparing an effective quality management system as required by EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). The aim of the seminar is to prepare medical device manufacturers' personnel to establish and maintain a quality management system that will be able to demonstrate compliance with the requirements of the MDR or IVDR without any problems during an audit by a notified body or an inspection by the CQA. The main program of the seminar is to clarify the often overlooked differences between the requirements of EN ISO 13485 and the requirements of both EU regulations. As the requirements of EN ISO 13485 are often not consistently required in voluntary certification, we will also briefly recapitulate the most frequently neglected requirements of this standard in the seminar. Most of the time will be spent on the differences between the MDR and IVDR requirements and the requirements of EN ISO 13485. The seminar will include a demonstration of common mistakes, practical audit experience and illustrative examples of solutions.

Who the webinar is for:

• personnel responsible for implementing and maintaining a quality management system according to MDR or IVDR requirements

• quality management representatives

• employees of specialized departments who need to understand what and why they are required to have a quality management system (e.g. purchasing, development, production)

• management representatives and business owners who want to understand how they can use a mandatory quality management system as an effective management tool

• internal auditors of the quality management system

• manufacturers who are preparing for certification of their quality management system by a notified body according to the requirements of the MDR or IVDR

• manufacturers starting out at the stage of medical device development and prototype production

• anyone with an active interest in quality management systems in the medical device field

• the seminar is not intended for complete beginners who have no practical or theoretical experience with any quality management system

Lecturers:

• Aleš Martinovský

• Barbora Charvátová

Content:

• basic legislative requirements for a quality management system

• quality management system as a business advantage

• the right time to implement a quality management system and how to do it practically

• EN ISO 13485 and the most common problems

• point-by-point comparison of EN ISO 13485 and MDR/IVDR requirements

• some specifics of MDR/IVDR in detail

• examples of how selected requirements are met

• specificities of small and micro enterprises

• internal audit as an obligation and as a useful tool

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

• ID: 03301931, VAT: CZ03301931

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