SIQ: Online workshop: US Regulation 21 CFR 820 for Medical Devices and Registration Procedures 510(k)
This workshop will be in English and is part of our academy cooperation with the Slowenian notified body SIQ!
About the training
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
Costs
- 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.
Your Trainer
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.
Location: ONLINE
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.
Click here to book now!
Don’t forget to use this code for a special 10 % en.co.tec-discount: encosiq10
For questions please text: office@encotec.at or call +43 1 8863491
This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!