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MDR, 2017/745 Excerpts from Annex I 49 Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Technical Documentation DIN EN ISO 14971 – Content – Foreword – Introduction – – – – – – – – – – Chapter 1: Scope Chapter 2: Normative references Chapter 3: Terms and definitions Chapter 4: General requirements for ______ management system
risk
Risk assessment consists of a risk analysis together with an evaluation of the ______
risk
Risk management is the extension to a risk control and an evaluation of the residual ______
risks
Risk management is a living document throughout the entire ______ of the product
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URS: A pen that is easy to write with – DRS: The ink flow of the pen shall be 100 - 120 mg/km – ______: Test reveals ink flow is 107 +/- 4 mg/km – Validation: Test with probands reveal 90% are satisfied with the easiness to write
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– Example: – URS: A pen that is easy to write with – DRS: The ink flow of the pen shall be 100 - 120 mg/km – Verification: Test reveals ink flow is 107 +/- 4 mg/km – ______: Test with probands reveal 90% are satisfied with the easiness to write
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– Quality Management System DIN EN ISO 13485 – Main Aspects: Chapter 7 (part 1/2) Plan and document development – – – – – – 36 Customer related requirements (URS) ______ and Validation Documentation of design evolution Documentation of design reviews and decision Traceability of design improvements Design and development file for each product
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– Quality Management System DIN EN ISO 13485 – Main Aspects: Chapter 7 (part 1/2) Plan and document development – – – – – – 36 Customer related requirements (URS) Verification and ______ Documentation of design evolution Documentation of design reviews and decision Traceability of design improvements Design and development file for each product
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– – – – – 31 Quality policy is top management responsibility Commitment of top management Quality management representative Training and internal communication Management reviews and internal audits Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Quality Management System DIN EN ISO 13485 - Excerpts DIN EN ISO 13485, 2016: Medizinprodukte - Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke.Excerpt from chapter 7 32 Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Quality Management System DIN EN ISO 13485 - Excerpts DIN EN ISO 13485, 2016: Medizinprodukte - Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke.Excerpt from chapter 7 33 Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Quality Management System DIN EN ISO 13485 - Excerpts DIN EN ISO 13485, 2016: Medizinprodukte - Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke.Excerpt from chapter 7 34 Artificial Organs - Regulation (Europe) e.g.using the V-Model Medical Regulation (Europe) – Quality Management System Product development – The V-model – A structured process for the development of products.
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32 Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Quality Management System DIN EN ISO 13485 - Excerpts DIN EN ISO 13485, 2016: Medizinprodukte - Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke.Excerpt from chapter 7 33 Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Quality Management System DIN EN ISO 13485 - Excerpts DIN EN ISO 13485, 2016: Medizinprodukte - Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke.Excerpt from chapter 7 34 Artificial Organs - Regulation (Europe) e.g.using the V-Model Medical Regulation (Europe) – Quality Management System Product development – The V-model – A structured process for the development of products.
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33 Artificial Organs - Regulation (Europe) Medical Regulation (Europe) – Quality Management System DIN EN ISO 13485 - Excerpts DIN EN ISO 13485, 2016: Medizinprodukte - Qualitätsmanagementsysteme Anforderungen für regulatorische Zwecke.Excerpt from chapter 7 34 Artificial Organs - Regulation (Europe) e.g.using the V-Model Medical Regulation (Europe) – Quality Management System Product development – The V-model – A structured process for the development of products.
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Medical Regulation (Europe) – Quality Management System Product development – The V-model – A structured process for the development of products.
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