Medical Devices

Program

US regulation 21 CFR 820 and registration procedures 510(k)

Workshop and materials will be in English language.

Regulatory requirements for medical devices on US, European, or other global markets differ.  Prior to a successful sale on the US market the medical device shall be registered (e.g. procedure acc. 510(k)),  and should adhere to the quality system regulation principles outlined in acc. 21 CFR 820. .

Intention

Attendees will be informed of the main regulation for medical devices on the US market, 21 CFR 820, and other related regulations for medical devices (e.g. 21 CFR 803, 806, 11). The basic principles of registration processes such as 510(k) will also be discussed using practical cases.

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

Lecturer

Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous work with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards.

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.

Who should attend this workshop?

  • Medical device manufacturers
  • Design and development, quality control specialists and those responsible for the production of medical devices
  • Responsible persons for regulatory affairs and medical device registration
  • All who would like to upgrade and refresh their knowledge on medical devices in the US market