Name [ DevCourseWeb.com ] Udemy - GSPR (General Safety and Performance Requirements) for SaMD
File Type video
Size 1.50GB
UpdateDate 2024-10-9
hash *****D63DBB66B87C3785B31CFCAA428D38BD05
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Files Get Bonus Downloads Here.url | 182B ~Get Your Files Here !/1. Introduction/1. Introduction.mp4 | 46.76MB ~Get Your Files Here !/1. Introduction/1. Introduction.srt | 7.34KB ~Get Your Files Here !/1. Introduction/1.1 F1.02 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Template (V1.0).docx | 74.66KB ~Get Your Files Here !/1. Introduction/1.2 REGULATION (EU) 2017745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices.html | 133B ~Get Your Files Here !/2. Harmonised standards for medical devices/1. Harmonised standards for medical devices.mp4 | 47.28MB ~Get Your Files Here !/2. Harmonised standards for medical devices/1. Harmonised standards for medical devices.srt | 9.06KB ~Get Your Files Here !/2. Harmonised standards for medical devices/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 | 183B ~Get Your Files Here !/2. Harmonised standards for medical devices/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 | 112B ~Get Your Files Here !/2. Harmonised standards for medical devices/1.3 How do you know if a standard is Harmonised.html | 161B ~Get Your Files Here !/2. Harmonised standards for medical devices/1.4 MDCG 2021-5 Guidance on standardisation for medical devices April 2021.html | 145B ~Get Your Files Here !/2. Harmonised standards for medical devices/1.5 References of harmonised standards and of other European standards published in the OJEU.html | 145B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1. Chapter I General Requirements SaMD.mp4 | 393.57MB ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1. Chapter I General Requirements SaMD.srt | 77.72KB ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.1 COMMISSION REGULATION (EU) No 2072012 on electronic instructions for use of medical devices.html | 285B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.2 EN 301 549 V3.2.1 (2021-03) Accessibility requirements for ICT products and services.html | 152B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.3 MDCG 2018-5 UDI Assignment to Medical Device Software.html | 106B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.4 MDCG 2019-16 - Guidance on Cybersecurity for medical devices.html | 106B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.5 MDCG 2020-1 Guidance on Clinical Evaluation (MDR) Performance Evaluation (IVDR) of Medical Device Software.html | 106B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.6 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies.html | 106B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.7 MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies.html | 106B ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.8 MHRA Medical device stand-alone software including apps.html | 146B ~Get Your Files Here !/4. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD)/1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).mp4 | 554.64MB ~Get Your Files Here !/4. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD)/1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).srt | 114.78KB ~Get Your Files Here !/5. CHAPTER III of General Safety and Performance requirements (SaMD)/1. CHAPTER III, Requirements Regarding the Information Supplied with the.mp4 | 473.54MB ~Get Your Files Here !/5. CHAPTER III of General Safety and Performance requirements (SaMD)/1. CHAPTER III, Requirements Regarding the Information Supplied with the.srt | 86.14KB ~Get Your Files Here !/5. CHAPTER III of General Safety and Performance requirements (SaMD)/1.1 COMMISSION REGULATION (EU) No 2072012 of 9 March 2012 on electronic instructions for use of medical devices.html | 285B ~Get Your Files Here !/5. CHAPTER III of General Safety and Performance requirements (SaMD)/1.2 MDCG 2018-5 UDI Assignment to Medical Device Software.html | 106B ~Get Your Files Here !/5. CHAPTER III of General Safety and Performance requirements (SaMD)/1.3 MHRA Medical devices software applications (apps).html | 146B ~Get Your Files Here !/6. Final Notes/1. Final Notes.mp4 | 15.31MB ~Get Your Files Here !/6. Final Notes/1. Final Notes.srt | 3.58KB ~Get Your Files Here !/Bonus Resources.txt | 357B
