April 18, 2018 - April 20, 2018
Date: 18 - 20 April 2018
Location: Nanjing, China
Language of instruction: English
Price: 4500 RMB
- To understand how the regulatory requirements in the new Medical Device Regulation (MDR) will have an effect on design and development of medical devices.
- To be able to design and develop a medical device, with focus on HW and SW, and build a technical file to obtain CE mark in Europe.
- To understand the consequences of the General Data Protection Regulation (GDPR) has on HW and SW design of medical devices and systems.
- To implement the requirements of HW & SW specific of key harmonized standards in the design and development of medical devices to comply to the general safety & performance requirements.
Regulatory framework: MDR
Medical Device Software lifecycle: IEC 62304
Risk Management: IEC 14971
Usability & Human Factors Engineering: IEC 62366
Data control, security & privacy: GDPR, ISO80001-1, IEC27001
Medical electrical equipment – safety and essential performance: IEC60601-1
Questions & Answers