Handbook of Medical Device Design. (2000)

• Record Type: Book
• Further Information: Note: Richard C. Fries.
• Authors: Fries, Richard C
• Contents: Cover; Half Title; Title Page; Copyright Page; Preface; Contents; Contributors; Section 1 Standards and Regulations; Chapter 1 FDA Regulations; 1.1 History of Device Regulation; 1.2 Device Classification; 1.2.1 Class I Devices; 1.2.2 Class II Devices; 1.2.3 ClassmDevices; 1.3 Registration and Listing; 1.4 Good Laboratory Practices (GLP); 1.5 Good Manufacturing Practices (GMP); 1.6 Human Factors; 1.7 Design Control; 1.8 Software; 1.9 The FDA Inspection; 1.10 Dealing witb the FDA; References; Chapter 2 Preparing an FDA Submission; 2.1 Deviee Classification; 2.1.1 Class I Devices 2.1.2 Class II Devices2.1.3 ClassmDevices; 2.2 The Traditional 510(k); 2.2.1 Determining Substantial Equivalency; 2.2.2 Preparing a 510(k); 2.2.2.1 Types of 510(k)5; 2.2.2.2 The 510(k) Format; 2.3 SpeciaI 510(k); 2.3.1 Special 510(k) Content; 2.4 Abbreviated 510(k); 2.4.1 Abbreviated 510(k) Content; 2.5 Declaration of Conformity to a Recognized Standard; 2.6 PMA Application; 2.6.1 The PMA Application Process; 2.6.2 Contents of a PMAA; 2.7 Investigational Delice Exemptions; 2.7.1 Institutional Review Boards (lRBs); 2.7.2 IDE Format; 2.8 Software Classification; References Chapter 3 European Standards and Regulations3.1 The European Regulatory Scene; 3.2 European Directives; 3.3 European Standardization Bodies; 3.4 European Standards Development Process; 3.4.1 New Work; 3.4.2 Development; 3.4.3 Public Enquiry; 3.4.4 Formal Vote; 3.4.5 Publication; 3.5 Other European Standards Considerations; 3.5.1 Primary Questionnaire Procedure; 3.5.2 Dual Regional and International Work; 3.5.3 Parallel Voting; 3.5.4 Unique Acceptance Procedure; 3.6 Conformity Assessment and Testing; 3.6.1 The CE Mark; 3.6.2 The Keymark; 3.7 European Organization for Testing and Certification 3.8 Examples of European DirectilPes and Regulations3.8.1 Tbe ISO Guidance Documents for ISO 9001 and 9002; 3.8.2 ISO 14000 Series; 3.9 Medical Informatics; 3.10 The Global Harmonization Task Force; 3.10.1 Objectives oftbe Task Force; 3.10.2 Philosophy of the Task Force; 3.10.3 Current Activities; References; Chapter 4 The Medical Device Directives; 4.1 Definition of a Medical Device; 4.2 The Medical Device Directives Process; 4.3 Choosing tbe Appropriate Directive; 4.4 Identifying the Applicable Essential Requirements; 4.5 Identification of Corresponding Harmonized Standards 4.6 Assurance tbat tbe Device Meets tbe Essential Requirements and Harmonized Standards4.7 Classification of the Device; 4.8 Decision on the Appropriate Conformity Assessment Procedure; 4.9 Type Testing; 4.10 Identification and Choice of a Notified Body; 4.11 Establisbing a Declaration of Conformity; 4.12 Application of the CE Mark; 4.13 Conclusion; References; Chapter 5 The Basics of ISO 9001; 5.1 Historical Perspective; 5.2 ISO 9001 Revision Year 2000; 5.3 Requirement Synopses; 5.3.1 Management Responsibilities; 5.3.2 Quality System; 5.3.3 Contract Review; 5.3.4 Design Control
• Publisher Details: Boca Raton, FL : CRC Press
• Publication Date: 2000
• Extent: 1 online resource
• Subjects: 681/.761; Biomedical engineering; Biomedical materials; Science; Biomedical engineering; Biomedical materials; Science; Electronic books
• Languages: English
• ISBNs: 9781482290028; 1482290022
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.