Timiri Shanmugam Prakash Srinivasan Sampath (37 results)

Condition: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Condition: New.

Condition: New. 1st ed. 2022 edition NO-PA16APR2015-KAP.

Taschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points.

Taschenbuch. Condition: Neu. Neuware -This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing.A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 392 pp. Englisch.

Condition: New. In.

Buch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This comprehensive resourceexplains the FDA'sclassification of devices andprovidesexpert guidance ondifferentiatingbetween significant risk and non-significant risk medical device studies.The book isdivided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapterincludesa general introduction and overview of the device, along with guidance onitsworking principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject.Thecoverage alsoincludesreports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devicesisdesignedto assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.

Hardcover. Condition: new. Hardcover. This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development. This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.

Buch. Condition: Neu. Neuware -Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 444 pp. Englisch.

Buch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points.

Condition: New.

Condition: New. 2024th edition NO-PA16APR2015-KAP.

Condition: New. 1st edition NO-PA16APR2015-KAP.

Hardcover. Condition: Brand New. 441 pages. 9.26x6.11x9.21 inches. In Stock.

Hardcover. Condition: new. Hardcover. This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development. This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability.

Hardcover. Condition: new. Hardcover. This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development. This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.

Condition: New. 1st ed. 2022 edition NO-PA16APR2015-KAP.

Condition: New.

Condition: New.

Condition: New. In.

Condition: New.

Condition: As New. Unread book in perfect condition.

Condition: As New. Unread book in perfect condition.

Condition: New. &Uumlber den AutorPrakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME-Biocompatibility at Baxter International, Inc. in Roun.

Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical De.

Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points. 392 pp. Englisch.

Gebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Prakash Srinivasan Timiri Shanmugam, Ph.D., ERT, is currently a senior toxicologist at Avanos Medical, Inc. Before Avanos Medical, he was a subject matter expert in biocompatibility at Baxter International, Inc. and Johnson & Johnson. Dr. Timiri S.

Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This comprehensive resourceexplains the FDA'sclassification of devices andprovidesexpert guidance ondifferentiatingbetween significant risk and non-significant risk medical device studies.The book isdivided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapterincludesa general introduction and overview of the device, along with guidance onitsworking principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject.Thecoverage alsoincludesreports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devicesisdesignedto assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development. 433 pp. Englisch.

Gebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. A critical resource for researchers and professionals in the medical device fieldThoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDRPresents simplified guidelines and regulation points.This comprehensiv.

Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points. 392 pp. Englisch.