[ DevCourseWeb.com ] Udemy - GSPR (General Safety and Performance Requirements) for SaMD
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- ~Get Your Files Here !/4. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD)/1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).mp4 554.6 MB
- ~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 473.5 MB
- ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1. Chapter I General Requirements SaMD.mp4 393.6 MB
- ~Get Your Files Here !/2. Harmonised standards for medical devices/1. Harmonised standards for medical devices.mp4 47.3 MB
- ~Get Your Files Here !/1. Introduction/1. Introduction.mp4 46.8 MB
- ~Get Your Files Here !/6. Final Notes/1. Final Notes.mp4 15.3 MB
- ~Get Your Files Here !/4. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD)/1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).srt 114.8 KB
- ~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 86.1 KB
- ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1. Chapter I General Requirements SaMD.srt 77.7 KB
- ~Get Your Files Here !/1. Introduction/1.1 F1.02 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Template (V1.0).docx 74.7 KB
- ~Get Your Files Here !/2. Harmonised standards for medical devices/1. Harmonised standards for medical devices.srt 9.1 KB
- ~Get Your Files Here !/1. Introduction/1. Introduction.srt 7.3 KB
- ~Get Your Files Here !/6. Final Notes/1. Final Notes.srt 3.6 KB
- ~Get Your Files Here !/Bonus Resources.txt 357 bytes
- ~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 285 bytes
- ~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 285 bytes
- ~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 183 bytes
- Get Bonus Downloads Here.url 182 bytes
- ~Get Your Files Here !/2. Harmonised standards for medical devices/1.3 How do you know if a standard is Harmonised.html 161 bytes
- ~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 152 bytes
- ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.8 MHRA Medical device stand-alone software including apps.html 146 bytes
- ~Get Your Files Here !/5. CHAPTER III of General Safety and Performance requirements (SaMD)/1.3 MHRA Medical devices software applications (apps).html 146 bytes
- ~Get Your Files Here !/2. Harmonised standards for medical devices/1.4 MDCG 2021-5 Guidance on standardisation for medical devices April 2021.html 145 bytes
- ~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 145 bytes
- ~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 133 bytes
- ~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 112 bytes
- ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.3 MDCG 2018-5 UDI Assignment to Medical Device Software.html 106 bytes
- ~Get Your Files Here !/3. CHAPTER I General Requirements (SaMD)/1.4 MDCG 2019-16 - Guidance on Cybersecurity for medical devices.html 106 bytes
- ~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 106 bytes
- ~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 106 bytes
- ~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 106 bytes
- ~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 106 bytes
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