000			04048cam a2200373 i 4500
001			on1228035595
003			OCoLC
005			20240726104831.0
008			201226s2021 onc ob 001 0 eng d
040			_aEBLCP _beng _erda _cEBLCP _dUKAHL _dOCLCQ _dNT _dYDX
020			_a9781774078235
050	0	4	_aK3611 _b.S567 2021
049			_aMAIN
100	1		_aNaidoo, Shalinee, _e1
245	1	0	_aA simple guide to understanding medical device regulations /Shalinee Naidoo.
300			_a1 online resource (xxii, 243 pages)
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_adata file _2rda
504			_a2
505	0	0	_aChapter 1 Introduction -- _tChapter 2 What is a Medical Device? -- _tChapter 3 Classification of Medical Devices -- _t3.1. Factors Influencing Device Classification Schemes -- _t3.2. Initial Classification Rules As Defined By The Global Harmonization Task Force -- _t3.3. Eu Guidelines On Medical Device Classification -- _t3.4. Understanding How To Apply The Rules Of Medical Device Classification
505	0	0	_a3.5. How To Apply The Eu Medical Device Classification Rules -- _t3.6. Understanding The Rules Governing Guidelines For The Classification Of Medical Devices According To Meddev 2.4/1 -- _tChapter 4 History of Medical Device Regulations -- _tChapter 5 Understanding the 2001 Model Regulatory Program for Medical Devices as Laid Out By WHO -- _t5.1. Understanding Section I: Guiding Principles And Essential Features Of A Regulatory Program For Medical Devices -- _t5.2. Understanding Section Ii: A Modular Approach To A Regulatory Program For Medical Devices
505	0	0	_a5.3. Understanding Section Iii: Reuse of Medical Devices -- _tChapter 6 Safety of Medical Devices -- _t6.1. How Do We Ensure Safety of Medical Devices? -- _t6.2. Safety In Relation To Performance Of A Medical Device -- _tChapter 7 Assessing The Effectiveness/Performance Of Medical Devices -- _t7.1. Participants In Ensuring The Safety of Medical Devices -- _t7.2. Understanding The Role Of Each Participant -- _t7.3. Shared Responsibilities For Safety And Performance of Medical Devices -- _tChapter 8 Conformity Assessments of Medical Devices -- _t8.1. Quality Management System (QMS)
505	0	0	_a8.2. System For Post-Market Surveillance -- _t8.3. Technical Documentation -- _t8.4. Declaration Of Conformity -- _t8.5. Registration Of Manufacturers And Their Medical Devices by The Regulatory Authority -- _tChapter 9 Understanding Sted (Summary Technical Documentation) -- _t9.1. What Is The Purpose Of Sted? -- _t9.2. The Use Of Sted In The Premarket Phase -- _t9.3. The Use Of The Sted In The Post-Market Phase -- _t9.4. Contents Of Sted -- _tChapter 10 Standards -- _t10.1. What Are Standards? -- _t10.2. Types Of Standard Specifications -- _t10.3. The Purpose Of Standards -- _t10.4. Types Of Standards
505	0	0	_a10.5. Development Process Of Standards -- _t10.6. Key Principles In The Development Of Iso Standards (As Defined By ISO) -- _t10.7. Conformity Assessment With Standards -- _t10.8. National And International Standard Systems -- _t10.9. Identification Of Standards -- _t10.10. The Use Of Standards In Medical Device Regulations -- _tChapter 11 The Global Harmonized Task Force -- _tChapter 12 Nomenclature Of Medical Devices -- _t12.1. The Global Medical Devices Nomenclature System -- _t12.2. Development Of GMDN -- _t12.3. Understanding The Purpose Of GMDN -- _t12.4. Compilation Of The Initial GMDN Nomenclature Database -- _t12.5. Understanding The Structure Of The Global Medical Device Nomenclature System.
530			_a2 _ub
650		0	_aMedical instruments and apparatus _xSafety regulations.
655		1	_aElectronic Books.
856	4	0	_zClick to access digital title | log in using your CIU ID number and my.ciu.edu password. _uhttpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2713644&site=eds-live&custid=s3260518
942			_cOB _D _eEB _hK. _m2021 _QOL _R _x _8NFIC _2LOC
994			_a92 _bNT
999			_c79856 _d79856
902			_a1 _bCynthia Snell _c1 _dCynthia Snell