Medidee Services SA Chemin de Rovéréaz 5 CH-1012 Lausanne
PHONE I +41 21 311 20 59 EMAIL I [email protected] WEB I www.medidee.com
2019-11-28 FactSheet_US-Regulations.docx ISO 9001 & ISO 13485 Certified company
US Regulations Overview of QSR, FDA inspections and market access
Duration: 1 day
Training objectives: • Understand the basis of the US Quality System Regulation • Understand the basis of the US Medical Device Regulation • Get acquainted with the FDA Medical Devices Databases • Understand the FDA inspection process and how to be prepared • Understand differences between US and EU regulatory framework
Training content: • US Quality System Regulation (QSR):
o Presentation of the FDA and its role o Introduction to the QSR o Similarities and differences between US and EU quality management systems
• FDA Inspection: o Steps of an FDA inspection o Guidance o Preparation of an inspection o Behaviour during an inspection o Outcomes of an inspection, including the consequences of a failed inspection
• US Medical Device Regulation: o Regulatory Framework o Classifications: 510(k), De Novo, HDE, PMA o Pre-Submission and Breakthrough Devices Programs o Searching FDA Medical Devices Databases o Similarities and differences between US and EU regulatory frameworks
The training is delivered by Jurjen Zoethout, Senior Associate and William Enns-Bray, Project Associate at Medidee Services. Price: CHF 750.- | Location: Medidee Services SA | Chemin de Rovéréaz 5 | 1012 Lausanne, Switzerland Contact & registration: [email protected]
