Online workshop: Requirements for Business Entities and Documentation Requirements for Medical Devices (GDP) – Regulations and Records (Regulation (EU) 2017/745)

This workshop will present the requirements of ISO 13485:2016 standard (EN) for a quality management system in the manufacture of medical devices (and related services) and the medical device legislation supported by this standard. From this legislation (Regulation EU 2017/745 on Medical Devices), we will address the requirements for the business entities that can be involved in placing medical devices on the market.

The current legislation and the standard require a high level of documentation in this process, and we will look at both the rules for this documentation and the resulting records.

Aim

The fundamental aim of the standard and the legislation is to ensure that only safe and effective medical devices are used in the Common European Market and beyond.

This training course will provide you with the knowledge that will help you be aware of your role as a business entity, establish and/or maintain a relevant quality management system, prepare documentation or technical files for medical devices, and master the requirements for relevant records.

Uroš Tacar has more than 25 years of experience in medical devices and in the field of development and legislation. He participated in the establishment of the quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of development manager and representative of the quality management. Among the most important tasks, he led the production and maintenance of technical folders of medical devices. He is a consultant and works at SIQ as a lecturer and long-term assessor in the field of medical devices