Online workshop: US Regulation 21 CFR 820 for Medical Devices and Registration Procedures 510(k)

Content

• Presentation of the regulations and requirements for medical devices on the US market with practical cases and discussions

• Methodology and registration documentation preparation

• Presentation of the registration process, assurance of compliance for FDA inspections

Course and materials will be in English language.

Lecturer Matija Rupnik has been active in the field of medical devices, their development and related legislation since the beginning of his career. He has participated in the establishment of quality systems in accordance with international legislation and in ensuring the compliance of active medical devices. For manufacturers, he performed the tasks of integrating quality management systems, determining regulatory strategies, and ensuring the compliance of medical devices, including the production and maintenance of medical device technical documentation. He is currently the head of regulatory matters at one of the manufacturers and an SIQ auditor.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.  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.

Certification procedure

Main steps in the process of obtaining the CE mark and more about certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.

Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si