About the training
This training course 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.
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.
- Overview of the requirements of (EN) ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purpose
- Explanation of the regulatory requirements for participating legal entities
- Explanation of the requirements of the standard for management system documentation
- Methods for controlling quality management system documentation
- General on the preparation of technical documentation
- Records as evidence of the implementation of the requirements of the standard and legislation
- Standard: 475,00 EUR (excl. VAT)
- Get your special 10 % en.co.tec-discount with this code: encosiq10
- incl. seminar documents as PDF and a certificate of participation.
Uroš Tacar has more than 25 years of experience with medical devices and the field of development and legislation. He participated in the establishment of a quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of head of development and representative of quality management. Among the more important tasks, he managed the production and maintenance of technical files of medical devices. He currently works as an assessor at SIQ and a consultant in the field of medical devices.
The online workshop will take place in a live online e-classroom. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.