Training: Developing Hardware & Software under the MDR

April 18, 2018 - April 20, 2018 / China

Date: 18 - 20 April 2018

Location: Nanjing, China

Language of instruction: English

Price: 4500 RMB




Lea
rning objectives:

 

  • 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.

  

Program Overview:

Introduction
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
UDI
Questions & Answers
Closure

  

 

Profile:

René Schings
Post date: April 03, 2018
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