Risk Management for Medical Device Manufacturers: [MD and IVD]
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
La Vergne
ASQ Quality Press
2022
|
| Schlagworte: | |
| Online-Zugang: | HWR01 |
| Beschreibung: | Description based on publisher supplied metadata and other sources |
| Beschreibung: | 1 Online-Ressource (259 Seiten) |
| ISBN: | 9781636940403 |
Internformat
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| 100 | 1 | |a Simon, Joe W. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Risk Management for Medical Device Manufacturers |b [MD and IVD] |
| 264 | 1 | |a La Vergne |b ASQ Quality Press |c 2022 | |
| 264 | 4 | |c ©2022 | |
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| 505 | 8 | |a Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Dedication -- Acknowledgments -- Preface -- List of Abbreviations -- Section 1_Building a Risk Program -- Chapter 1_The Scope of Risk Management -- Chapter 2_What is "Risk"? -- Chapter 3_The Sequence of Events-What to Measure -- Chapter 4_Control and Monitoring of the Sequence of Events -- Chapter 5_How to Define Occurrence Criteria in the RMP -- Chapter 6_How to Define Severity Criteria-A Master Harms List -- Chapter 7_Establishing Design Inputs and Process Controls -- Chapter 8_Risk Analysis and Evaluation -- Section 2_Risk in Verification/Validation -- Chapter 9_Determining What's Critical to Quality -- Chapter 10_AQL or LTPD? -- Chapter 11_Confidence -- Chapter 12_Reliability -- Chapter 13_How to Distribute Samples-The Invalid Assumption -- Chapter 14_Continued Process Verification -- Chapter 15_Test Method Validation -- Section 3_Using Risk -- Chapter 16_What is the Requirement? -- Chapter 17_Risk-Based Decisions Regarding the Need for an Investigation -- Chapter 18_Quality System Nonconformities -- Section 4_Information for Users/Patients -- Chapter 19_Two Types of Information -- Chapter 20_Warnings, Precautions, Contraindications, and Adverse Reactions/Events -- Chapter 21_Information for Safety and Training -- Chapter 22_Residual Risk -- Section 5_Other Information -- Chapter 23_More Bad Guidance in ISO 14971:2019 -- Chapter 24_Linking Your FMEAs (NCEAs) -- Chapter 25_Overlapping Definitions -- Chapter 26_Quality Data for Post-Market Surveillance -- Chapter 27_Why Investigations Are Illegal in a Nonconformance Report (NCR) -- Chapter 28_Don't Blame the People -- Chapter 29_Flowcharts -- Summary of Key Takeaways -- Checklist of Questions -- Bibliography -- Index -- About the Author | |
| 650 | 4 | |a Medical instruments and apparatus-Safety measures | |
| 650 | 4 | |a Medical instruments and apparatus industry-Risk management | |
| 650 | 4 | |a Medical instruments and apparatus-Quality control | |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe |a Simon, Joe W. |t Risk Management for Medical Device Manufacturers |d La Vergne : ASQ Quality Press,c2022 |z 9781636940137 |
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Datensatz im Suchindex
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| author | Simon, Joe W. |
| author_facet | Simon, Joe W. |
| author_role | aut |
| author_sort | Simon, Joe W. |
| author_variant | j w s jw jws |
| building | Verbundindex |
| bvnumber | BV049019601 |
| collection | ZDB-30-PQE |
| contents | Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Dedication -- Acknowledgments -- Preface -- List of Abbreviations -- Section 1_Building a Risk Program -- Chapter 1_The Scope of Risk Management -- Chapter 2_What is "Risk"? -- Chapter 3_The Sequence of Events-What to Measure -- Chapter 4_Control and Monitoring of the Sequence of Events -- Chapter 5_How to Define Occurrence Criteria in the RMP -- Chapter 6_How to Define Severity Criteria-A Master Harms List -- Chapter 7_Establishing Design Inputs and Process Controls -- Chapter 8_Risk Analysis and Evaluation -- Section 2_Risk in Verification/Validation -- Chapter 9_Determining What's Critical to Quality -- Chapter 10_AQL or LTPD? -- Chapter 11_Confidence -- Chapter 12_Reliability -- Chapter 13_How to Distribute Samples-The Invalid Assumption -- Chapter 14_Continued Process Verification -- Chapter 15_Test Method Validation -- Section 3_Using Risk -- Chapter 16_What is the Requirement? -- Chapter 17_Risk-Based Decisions Regarding the Need for an Investigation -- Chapter 18_Quality System Nonconformities -- Section 4_Information for Users/Patients -- Chapter 19_Two Types of Information -- Chapter 20_Warnings, Precautions, Contraindications, and Adverse Reactions/Events -- Chapter 21_Information for Safety and Training -- Chapter 22_Residual Risk -- Section 5_Other Information -- Chapter 23_More Bad Guidance in ISO 14971:2019 -- Chapter 24_Linking Your FMEAs (NCEAs) -- Chapter 25_Overlapping Definitions -- Chapter 26_Quality Data for Post-Market Surveillance -- Chapter 27_Why Investigations Are Illegal in a Nonconformance Report (NCR) -- Chapter 28_Don't Blame the People -- Chapter 29_Flowcharts -- Summary of Key Takeaways -- Checklist of Questions -- Bibliography -- Index -- About the Author |
| ctrlnum | (ZDB-30-PQE)EBC7158791 (ZDB-30-PAD)EBC7158791 (ZDB-89-EBL)EBL7158791 (OCoLC)1356008401 (DE-599)BVBBV049019601 |
| dewey-full | 780 |
| dewey-hundreds | 700 - The arts |
| dewey-ones | 780 - Music |
| dewey-raw | 780 |
| dewey-search | 780 |
| dewey-sort | 3780 |
| dewey-tens | 780 - Music |
| discipline | Musikwissenschaft |
| discipline_str_mv | Musikwissenschaft |
| format | Electronic eBook |
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| id | DE-604.BV049019601 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T22:13:39Z |
| indexdate | 2024-07-10T09:52:58Z |
| institution | BVB |
| isbn | 9781636940403 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-034282508 |
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| physical | 1 Online-Ressource (259 Seiten) |
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| spelling | Simon, Joe W. Verfasser aut Risk Management for Medical Device Manufacturers [MD and IVD] La Vergne ASQ Quality Press 2022 ©2022 1 Online-Ressource (259 Seiten) txt rdacontent c rdamedia cr rdacarrier Description based on publisher supplied metadata and other sources Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Dedication -- Acknowledgments -- Preface -- List of Abbreviations -- Section 1_Building a Risk Program -- Chapter 1_The Scope of Risk Management -- Chapter 2_What is "Risk"? -- Chapter 3_The Sequence of Events-What to Measure -- Chapter 4_Control and Monitoring of the Sequence of Events -- Chapter 5_How to Define Occurrence Criteria in the RMP -- Chapter 6_How to Define Severity Criteria-A Master Harms List -- Chapter 7_Establishing Design Inputs and Process Controls -- Chapter 8_Risk Analysis and Evaluation -- Section 2_Risk in Verification/Validation -- Chapter 9_Determining What's Critical to Quality -- Chapter 10_AQL or LTPD? -- Chapter 11_Confidence -- Chapter 12_Reliability -- Chapter 13_How to Distribute Samples-The Invalid Assumption -- Chapter 14_Continued Process Verification -- Chapter 15_Test Method Validation -- Section 3_Using Risk -- Chapter 16_What is the Requirement? -- Chapter 17_Risk-Based Decisions Regarding the Need for an Investigation -- Chapter 18_Quality System Nonconformities -- Section 4_Information for Users/Patients -- Chapter 19_Two Types of Information -- Chapter 20_Warnings, Precautions, Contraindications, and Adverse Reactions/Events -- Chapter 21_Information for Safety and Training -- Chapter 22_Residual Risk -- Section 5_Other Information -- Chapter 23_More Bad Guidance in ISO 14971:2019 -- Chapter 24_Linking Your FMEAs (NCEAs) -- Chapter 25_Overlapping Definitions -- Chapter 26_Quality Data for Post-Market Surveillance -- Chapter 27_Why Investigations Are Illegal in a Nonconformance Report (NCR) -- Chapter 28_Don't Blame the People -- Chapter 29_Flowcharts -- Summary of Key Takeaways -- Checklist of Questions -- Bibliography -- Index -- About the Author Medical instruments and apparatus-Safety measures Medical instruments and apparatus industry-Risk management Medical instruments and apparatus-Quality control Erscheint auch als Druck-Ausgabe Simon, Joe W. Risk Management for Medical Device Manufacturers La Vergne : ASQ Quality Press,c2022 9781636940137 |
| spellingShingle | Simon, Joe W. Risk Management for Medical Device Manufacturers [MD and IVD] Cover -- Title page -- CIP data -- Contents -- List of Figures and Tables -- Dedication -- Acknowledgments -- Preface -- List of Abbreviations -- Section 1_Building a Risk Program -- Chapter 1_The Scope of Risk Management -- Chapter 2_What is "Risk"? -- Chapter 3_The Sequence of Events-What to Measure -- Chapter 4_Control and Monitoring of the Sequence of Events -- Chapter 5_How to Define Occurrence Criteria in the RMP -- Chapter 6_How to Define Severity Criteria-A Master Harms List -- Chapter 7_Establishing Design Inputs and Process Controls -- Chapter 8_Risk Analysis and Evaluation -- Section 2_Risk in Verification/Validation -- Chapter 9_Determining What's Critical to Quality -- Chapter 10_AQL or LTPD? -- Chapter 11_Confidence -- Chapter 12_Reliability -- Chapter 13_How to Distribute Samples-The Invalid Assumption -- Chapter 14_Continued Process Verification -- Chapter 15_Test Method Validation -- Section 3_Using Risk -- Chapter 16_What is the Requirement? -- Chapter 17_Risk-Based Decisions Regarding the Need for an Investigation -- Chapter 18_Quality System Nonconformities -- Section 4_Information for Users/Patients -- Chapter 19_Two Types of Information -- Chapter 20_Warnings, Precautions, Contraindications, and Adverse Reactions/Events -- Chapter 21_Information for Safety and Training -- Chapter 22_Residual Risk -- Section 5_Other Information -- Chapter 23_More Bad Guidance in ISO 14971:2019 -- Chapter 24_Linking Your FMEAs (NCEAs) -- Chapter 25_Overlapping Definitions -- Chapter 26_Quality Data for Post-Market Surveillance -- Chapter 27_Why Investigations Are Illegal in a Nonconformance Report (NCR) -- Chapter 28_Don't Blame the People -- Chapter 29_Flowcharts -- Summary of Key Takeaways -- Checklist of Questions -- Bibliography -- Index -- About the Author Medical instruments and apparatus-Safety measures Medical instruments and apparatus industry-Risk management Medical instruments and apparatus-Quality control |
| title | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_auth | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_exact_search | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_exact_search_txtP | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_full | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_fullStr | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_full_unstemmed | Risk Management for Medical Device Manufacturers [MD and IVD] |
| title_short | Risk Management for Medical Device Manufacturers |
| title_sort | risk management for medical device manufacturers md and ivd |
| title_sub | [MD and IVD] |
| topic | Medical instruments and apparatus-Safety measures Medical instruments and apparatus industry-Risk management Medical instruments and apparatus-Quality control |
| topic_facet | Medical instruments and apparatus-Safety measures Medical instruments and apparatus industry-Risk management Medical instruments and apparatus-Quality control |
| work_keys_str_mv | AT simonjoew riskmanagementformedicaldevicemanufacturersmdandivd |