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Medidee Services SA Chemin de Rovéréaz 5 CH-1012 Lausanne PHONE I +41 21 311 20 59 EMAIL I training@medidee.com 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]

US Regulations Overview of QSR, FDA inspections …...US Regulations Overview of QSR, FDA inspections and market access Duration: 1 day Training objectives: • Understand the basis

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Page 1: US Regulations Overview of QSR, FDA inspections …...US Regulations Overview of QSR, FDA inspections and market access Duration: 1 day Training objectives: • Understand the basis

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]