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

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

Torrent:	Udemy - GSPR (General Safety and Performance Requirements) for SaMD
Description:	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the essential requirements (ER) which were the core of the previous Medical Device Directive 93/42/EEC (MDD) have been replaced by the General Safety and Performance Requirements (GSPR).
Downloads:	21
Category:	Other /Tutorials
Size:	1.5 GB
Show Files »	[ DevCourseWeb.com ] Udemy - GSPR (General Safety and Performance Requirements) for SaMD Get Bonus Downloads Here.url (0.2 KB) ~Get Your Files Here ! 1. Introduction 1. Introduction.mp4 (46.8 MB) 1. Introduction.srt (7.3 KB) 1.1 F1.02 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Template (V1.0).docx (74.7 KB) 1.2 REGULATION (EU) 2017745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices.html (0.1 KB) 2. Harmonised standards for medical devices 1. Harmonised standards for medical devices.mp4 (47.3 MB) 1. Harmonised standards for medical devices.srt (9.1 KB) 1.1 Commission Implementing Decision (EU) 2020437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 9342EEC.html (0.2 KB) 1.2 Commission Implementing Decision (EU) 20211182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017745 of the European Parliament and of the Council.html (0.1 KB) 1.3 How do you know if a standard is Harmonised.html (0.2 KB) 1.4 MDCG 2021-5 Guidance on standardisation for medical devices April 2021.html (0.1 KB) 1.5 References of harmonised standards and of other European standards published in the OJEU.html (0.1 KB) 3. CHAPTER I General Requirements (SaMD) 1. Chapter I General Requirements SaMD.mp4 (393.6 MB) 1. Chapter I General Requirements SaMD.srt (77.7 KB) 1.1 COMMISSION REGULATION (EU) No 2072012 on electronic instructions for use of medical devices.html (0.3 KB) 1.2 EN 301 549 V3.2.1 (2021-03) Accessibility requirements for ICT products and services.html (0.1 KB) 1.3 MDCG 2018-5 UDI Assignment to Medical Device Software.html (0.1 KB) 1.4 MDCG 2019-16 - Guidance on Cybersecurity for medical devices.html (0.1 KB) 1.5 MDCG 2020-1 Guidance on Clinical Evaluation (MDR) Performance Evaluation (IVDR) of Medical Device Software.html (0.1 KB) 1.6 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies.html (0.1 KB) 1.7 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies.html (0.1 KB) 1.8 MHRA Medical device stand-alone software including apps.html (0.1 KB) 4. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD) 1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).mp4 (554.6 MB) 1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).srt (114.8 KB) 5. CHAPTER III of General Safety and Performance requirements (SaMD) 1. CHAPTER III, Requirements Regarding the Information Supplied with the.mp4 (473.5 MB) 1. CHAPTER III, Requirements Regarding the Information Supplied with the.srt (86.1 KB) 1.1 COMMISSION REGULATION (EU) No 2072012 of 9 March 2012 on electronic instructions for use of medical devices.html (0.3 KB) 1.2 MDCG 2018-5 UDI Assignment to Medical Device Software.html (0.1 KB) 1.3 MHRA Medical devices software applications (apps).html (0.1 KB) 6. Final Notes 1. Final Notes.mp4 (15.3 MB) 1. Final Notes.srt (3.6 KB) Bonus Resources.txt (0.3 KB) files
Added:	2021-11-04 10:06:53
Language:	English
Peers:	Seeders : 3 , Leechers : 4
Release name:	Udemy - GSPR (General Safety and Performance Requirements) for SaMD
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