Regulatory affairs for biomaterials and medical devices:
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedu...
Gespeichert in:
| Weitere Verfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Cambridge, England
Woodhead Publishing
2015
|
| Schriftenreihe: | Woodhead Publishing series in biomaterials
no. 79 |
| Schlagworte: | |
| Online-Zugang: | FLA01 URL des Erstveröffentlichers |
| Zusammenfassung: | All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo |
| Beschreibung: | Includes bibliographical references at the end of each chapters and index |
| Beschreibung: | 1 online resource (203 pages) illustrations |
| ISBN: | 9780857099204 0857099205 |
Internformat
MARC
| LEADER | 00000nmm a2200000zcb4500 | ||
|---|---|---|---|
| 001 | BV046126710 | ||
| 003 | DE-604 | ||
| 005 | 00000000000000.0 | ||
| 007 | cr|uuu---uuuuu | ||
| 008 | 190827s2015 |||| o||u| ||||||eng d | ||
| 020 | |a 9780857099204 |9 978-0-85709-920-4 | ||
| 020 | |a 0857099205 |9 0-85709-920-5 | ||
| 035 | |a (ZDB-33-ESD)ocn896853548 | ||
| 035 | |a (OCoLC)896853548 | ||
| 035 | |a (DE-599)BVBBV046126710 | ||
| 040 | |a DE-604 |b ger |e rda | ||
| 041 | 0 | |a eng | |
| 082 | 0 | |a 344.041 |2 23 | |
| 245 | 1 | 0 | |a Regulatory affairs for biomaterials and medical devices |c edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others] |
| 264 | 1 | |a Cambridge, England |b Woodhead Publishing |c 2015 | |
| 264 | 4 | |c © 2015 | |
| 300 | |a 1 online resource (203 pages) |b illustrations | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 490 | 0 | |a Woodhead Publishing series in biomaterials |v no. 79 | |
| 500 | |a Includes bibliographical references at the end of each chapters and index | ||
| 520 | |a All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo | ||
| 650 | 7 | |a TECHNOLOGY & ENGINEERING / Engineering (General) |2 bisacsh | |
| 650 | 7 | |a TECHNOLOGY & ENGINEERING / Reference |2 bisacsh | |
| 650 | 7 | |a Medical instruments and apparatus / Safety regulations |2 fast | |
| 650 | 4 | |a Biocompatible Materials | |
| 650 | 4 | |a Device Approval | |
| 650 | 4 | |a Equipment Safety | |
| 650 | 4 | |a Medical instruments and apparatus |x Safety regulations | |
| 700 | 1 | |a Amato, Stephen F. |4 edt | |
| 700 | 1 | |a Ezzell, Robert M. |4 edt | |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe |z 0857095420 |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe |z 9780857095428 |
| 856 | 4 | 0 | |u http://www.sciencedirect.com/science/book/9780857095428 |x Verlag |z URL des Erstveröffentlichers |3 Volltext |
| 912 | |a ZDB-33-ESD | ||
| 999 | |a oai:aleph.bib-bvb.de:BVB01-031507164 | ||
| 966 | e | |u http://www.sciencedirect.com/science/book/9780857095428 |l FLA01 |p ZDB-33-ESD |q FLA_PDA_ESD |x Verlag |3 Volltext | |
Datensatz im Suchindex
| _version_ | 1804180447079432192 |
|---|---|
| any_adam_object | |
| author2 | Amato, Stephen F. Ezzell, Robert M. |
| author2_role | edt edt |
| author2_variant | s f a sf sfa r m e rm rme |
| author_facet | Amato, Stephen F. Ezzell, Robert M. |
| building | Verbundindex |
| bvnumber | BV046126710 |
| collection | ZDB-33-ESD |
| ctrlnum | (ZDB-33-ESD)ocn896853548 (OCoLC)896853548 (DE-599)BVBBV046126710 |
| dewey-full | 344.041 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 344 - Labor, social, education & cultural law |
| dewey-raw | 344.041 |
| dewey-search | 344.041 |
| dewey-sort | 3344.041 |
| dewey-tens | 340 - Law |
| discipline | Rechtswissenschaft |
| format | Electronic eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>02560nmm a2200481zcb4500</leader><controlfield tag="001">BV046126710</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">00000000000000.0</controlfield><controlfield tag="007">cr|uuu---uuuuu</controlfield><controlfield tag="008">190827s2015 |||| o||u| ||||||eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9780857099204</subfield><subfield code="9">978-0-85709-920-4</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0857099205</subfield><subfield code="9">0-85709-920-5</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ZDB-33-ESD)ocn896853548</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)896853548</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV046126710</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">344.041</subfield><subfield code="2">23</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Regulatory affairs for biomaterials and medical devices</subfield><subfield code="c">edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others]</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Cambridge, England</subfield><subfield code="b">Woodhead Publishing</subfield><subfield code="c">2015</subfield></datafield><datafield tag="264" ind1=" " ind2="4"><subfield code="c">© 2015</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 online resource (203 pages)</subfield><subfield code="b">illustrations</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="0" ind2=" "><subfield code="a">Woodhead Publishing series in biomaterials</subfield><subfield code="v">no. 79</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references at the end of each chapters and index</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">TECHNOLOGY & ENGINEERING / Engineering (General)</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">TECHNOLOGY & ENGINEERING / Reference</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Medical instruments and apparatus / Safety regulations</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Biocompatible Materials</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Device Approval</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Equipment Safety</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical instruments and apparatus</subfield><subfield code="x">Safety regulations</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Amato, Stephen F.</subfield><subfield code="4">edt</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Ezzell, Robert M.</subfield><subfield code="4">edt</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Druck-Ausgabe</subfield><subfield code="z">0857095420</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Druck-Ausgabe</subfield><subfield code="z">9780857095428</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://www.sciencedirect.com/science/book/9780857095428</subfield><subfield code="x">Verlag</subfield><subfield code="z">URL des Erstveröffentlichers</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-33-ESD</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-031507164</subfield></datafield><datafield tag="966" ind1="e" ind2=" "><subfield code="u">http://www.sciencedirect.com/science/book/9780857095428</subfield><subfield code="l">FLA01</subfield><subfield code="p">ZDB-33-ESD</subfield><subfield code="q">FLA_PDA_ESD</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield></record></collection> |
| id | DE-604.BV046126710 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T08:35:54Z |
| institution | BVB |
| isbn | 9780857099204 0857099205 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-031507164 |
| oclc_num | 896853548 |
| open_access_boolean | |
| physical | 1 online resource (203 pages) illustrations |
| psigel | ZDB-33-ESD ZDB-33-ESD FLA_PDA_ESD |
| publishDate | 2015 |
| publishDateSearch | 2015 |
| publishDateSort | 2015 |
| publisher | Woodhead Publishing |
| record_format | marc |
| series2 | Woodhead Publishing series in biomaterials |
| spelling | Regulatory affairs for biomaterials and medical devices edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others] Cambridge, England Woodhead Publishing 2015 © 2015 1 online resource (203 pages) illustrations txt rdacontent c rdamedia cr rdacarrier Woodhead Publishing series in biomaterials no. 79 Includes bibliographical references at the end of each chapters and index All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller companies who may not emplo TECHNOLOGY & ENGINEERING / Engineering (General) bisacsh TECHNOLOGY & ENGINEERING / Reference bisacsh Medical instruments and apparatus / Safety regulations fast Biocompatible Materials Device Approval Equipment Safety Medical instruments and apparatus Safety regulations Amato, Stephen F. edt Ezzell, Robert M. edt Erscheint auch als Druck-Ausgabe 0857095420 Erscheint auch als Druck-Ausgabe 9780857095428 http://www.sciencedirect.com/science/book/9780857095428 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Regulatory affairs for biomaterials and medical devices TECHNOLOGY & ENGINEERING / Engineering (General) bisacsh TECHNOLOGY & ENGINEERING / Reference bisacsh Medical instruments and apparatus / Safety regulations fast Biocompatible Materials Device Approval Equipment Safety Medical instruments and apparatus Safety regulations |
| title | Regulatory affairs for biomaterials and medical devices |
| title_auth | Regulatory affairs for biomaterials and medical devices |
| title_exact_search | Regulatory affairs for biomaterials and medical devices |
| title_full | Regulatory affairs for biomaterials and medical devices edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others] |
| title_fullStr | Regulatory affairs for biomaterials and medical devices edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others] |
| title_full_unstemmed | Regulatory affairs for biomaterials and medical devices edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S.F. Amato [and ten others] |
| title_short | Regulatory affairs for biomaterials and medical devices |
| title_sort | regulatory affairs for biomaterials and medical devices |
| topic | TECHNOLOGY & ENGINEERING / Engineering (General) bisacsh TECHNOLOGY & ENGINEERING / Reference bisacsh Medical instruments and apparatus / Safety regulations fast Biocompatible Materials Device Approval Equipment Safety Medical instruments and apparatus Safety regulations |
| topic_facet | TECHNOLOGY & ENGINEERING / Engineering (General) TECHNOLOGY & ENGINEERING / Reference Medical instruments and apparatus / Safety regulations Biocompatible Materials Device Approval Equipment Safety Medical instruments and apparatus Safety regulations |
| url | http://www.sciencedirect.com/science/book/9780857095428 |
| work_keys_str_mv | AT amatostephenf regulatoryaffairsforbiomaterialsandmedicaldevices AT ezzellrobertm regulatoryaffairsforbiomaterialsandmedicaldevices |