Udemy - GSPR (General Safety and Performance Requirements) for SaMD torrent

GSPR (General Safety and Performance Requirements) for SaMD
https://DevCourseWeb.com

MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Genre: eLearning | Language: English + srt | Duration: 6 lectures (4h 5m) | Size: 812.9 MB
MDR 2017/745 GSPR Evidence of conformance with standards and documentation for Software as a medical device (SaMD)
What you'll learn:
What is the GSPR (General Safety and Performance Requirement) acoording with for MDR2017/74
Relevance of GSPR in MDR CE Marking
MDR 2017/745 Annex I (GSPR) Main Chapters
Complete the GSPR using a case study for Software as a medical device (SaMD)
Ways to nstrate Conformity through GSPR

Requirements
No Medical Device Regulatory affairs experience needed. You will learn everything you need to know.

Description
With the EU Medical Device Regulation (MDR 2017/745) looming, medical device companies are focusing on ensuring compliance with the new regulations.

Within the EU Medical Device Regulation 2017/745, the essential requirements (ER) which were the core of the previous Medical Device Directive 93/42/EEC (MDD) have been replaced by the General Safety and Performance Requirements (GSPR).