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

Torrent Contents Size: 1.5 GB

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

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1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).mp4	MP4	554.6 MB
1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).srt	SRT	114.8 KB
1. CHAPTER III, Requirements Regarding the Information Supplied with the.mp4	MP4	473.5 MB
1. CHAPTER III, Requirements Regarding the Information Supplied with the.srt	SRT	86.1 KB
1. Chapter I General Requirements SaMD.mp4	MP4	393.6 MB
1. Chapter I General Requirements SaMD.srt	SRT	77.7 KB
1. Final Notes.mp4	MP4	15.3 MB
1. Final Notes.srt	SRT	3.6 KB
1. Harmonised standards for medical devices.mp4	MP4	47.3 MB
1. Harmonised standards for medical devices.srt	SRT	9.1 KB
1. Introduction.mp4	MP4	46.8 MB
1. Introduction.srt	SRT	7.3 KB
1.1 COMMISSION REGULATION (EU) No 2072012 of 9 March 2012 on electronic instructions for use of medical devices.html	HTML	307.2 B
1.1 COMMISSION REGULATION (EU) No 2072012 on electronic instructions for use of medical devices.html	HTML	307.2 B
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	HTML	204.8 B
1.1 F1.02 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Template (V1.0).docx	DOCX	74.7 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	HTML	102.4 B
1.2 EN 301 549 V3.2.1 (2021-03) Accessibility requirements for ICT products and services.html	HTML	102.4 B
1.2 MDCG 2018-5 UDI Assignment to Medical Device Software.html	HTML	102.4 B
1.2 REGULATION (EU) 2017745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices.html	HTML	102.4 B
1.3 How do you know if a standard is Harmonised.html	HTML	204.8 B
1.3 MDCG 2018-5 UDI Assignment to Medical Device Software.html	HTML	102.4 B
1.3 MHRA Medical devices software applications (apps).html	HTML	102.4 B
1.4 MDCG 2019-16 - Guidance on Cybersecurity for medical devices.html	HTML	102.4 B
1.4 MDCG 2021-5 Guidance on standardisation for medical devices April 2021.html	HTML	102.4 B
1.5 MDCG 2020-1 Guidance on Clinical Evaluation (MDR) Performance Evaluation (IVDR) of Medical Device Software.html	HTML	102.4 B
1.5 References of harmonised standards and of other European standards published in the OJEU.html	HTML	102.4 B
1.6 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies.html	HTML	102.4 B
1.7 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies.html	HTML	102.4 B
1.8 MHRA Medical device stand-alone software including apps.html	HTML	102.4 B
Bonus Resources.txt	TXT	307.2 B
Get Bonus Downloads Here.url	URL	204.8 B

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