Regulatory, quality and clinical affairs

Regulatory approval (European & Swiss Medical Devices Regulation)

• Context of the European regulatory framework, introduction on the Medical Device Regulation (MDR), the In-Vitro Diagnostic Device regulation (IVDR), and the Swiss Law on Therapeutical Products. Concept of harmonized and technical standards, key operators on the market.

Medical Device Regulation: Introduction and Classification

• Keys regulatory expectations with medical devices, qualification and classification of a medical device.

Medical Device Development - Validation & Verification

• Development stages of a medical device, key activities and optimal sequence from the development to the marketing of a medical device. Introduction to verifications and validations

Risk Management of Medical Devices

• Presentation of Risk Management principles applied to medical devices, application of ISO 14971

Quality Management System ISO 13485:2016

• Presentation of Quality Management System, key activities and processes to consider, application of ISO 13485 requirements

Clinical Activities - Good Clinical Practices

• Key principles when designing and conducting a clinical investigation for a medical device, introduction to Good Clinical Practices

Introduction to US Regulatory Framework

• Particularities of US market access process

Introduction to  Digital Health

• Particularities of Medical Devices Software, qualification of software as medical devices