Afbeelding 1 van 3
Medical Device Regulatory Practices by Val Theisz (2015, Hardcover) VG
Objectstaat:
“Clean Text. Great Condition.Most of our orders are shipped within 24 hours.”
Prijs:
US $67,99
OngeveerEUR 62,57
- Nu kopenMedical Device Regulatory Practices by Val Theisz (2015, Hardcover) VG
Beste voorstel:
Verzendkosten:
Bevindt zich in: Riverside, California, Verenigde Staten
Levering:
Geschatte levering tussen ma, 10 jun en wo, 12 jun tot 43230
Retourbeleid:
30 dagen om te retourneren. Koper betaalt voor retourzending. Details bekijken- voor meer informatie over retourzendingen
Betalingen:
Winkel met vertrouwen
Verkopergegevens
Ingeschreven als zakelijke verkoper
De verkoper neemt de volledige verantwoordelijkheid voor deze aanbieding.
eBay-objectnummer:285606869451
Specificaties
- Objectstaat
- Heel goed
- Opmerkingen van verkoper
- “Clean Text. Great Condition.Most of our orders are shipped within 24 hours.”
- ISBN
- 9789814669108
- Subject Area
- Medical
- Publication Name
- Medical Device Regulatory Practices
- Item Length
- 9.3 in
- Publisher
- Pan Stanford Publishing
- Subject
- Administration, Instruments & Supplies
- Publication Year
- 2015
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Item Height
- 1.4 in
- Item Width
- 6.4 in
- Item Weight
- 32.9 Oz
- Number of Pages
- 590 Pages
Over dit product
Product Information
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators' language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Product Identifiers
Publisher
Pan Stanford Publishing
ISBN-10
9814669105
ISBN-13
9789814669108
eBay Product ID (ePID)
211710471
Product Key Features
Publication Name
Medical Device Regulatory Practices
Format
Hardcover
Language
English
Subject
Administration, Instruments & Supplies
Publication Year
2015
Type
Textbook
Subject Area
Medical
Number of Pages
590 Pages
Dimensions
Item Length
9.3 in
Item Height
1.4 in
Item Width
6.4 in
Item Weight
32.9 Oz
Additional Product Features
Lc Classification Number
R856
Reviews
"I can only commend Val's book to all newcomers in the regulatory profession, be it in industry or in a regulatory agency. It explains the basics very well also for a start-up or an inventor who has to start dealing with regulations if he or she ever wants to market a product. I'm sure it could also be used as a valuable tool for those departments or ministries of health that want to set up a new national medical device regulatory agency in their jurisdictions. As it gives a global overview of how regulatory systems are applied in different legal settings and how industry should deal with these requirements, it is a unique guidance reference book for medical device regulations. Using the information contained in this book will make life easier for regulatory affairs professionals." -- Rainer Voelksen, Project Manager, Swiss Federal Office of Public Health, Chairman 2015, Regulatory Affairs Professionals Society (RAPS)
Table of Content
Overview of risk classification systems and regulatory controls for medical devices and IVDs in established markets and GHTF harmonization: definitions and basic terminology related to medical devices Core concepts of safety and effectiveness, use of standards, risk management, and clinical evaluation for medical devices Design History File (DHF) and technical documentation content and structure that satisfies requirements in all key markets: Summary Technical Documentation (STED) and Regulated Product Submission (RPS) Premarket design controls and an example of market access strategy template including regulatory strategy, clinical strategy, and reimbursement strategy Regulatory submissions and approvals in key markets Post-market regulatory controls including change management, post-market surveillance, performance of quality management systems, and regulatory systems and processes
Copyright Date
2015
Target Audience
College Audience
Dewey Decimal
610.28
Dewey Edition
23
Illustrated
Yes
Objectbeschrijving van de verkoper
De verkoper neemt de volledige verantwoordelijkheid voor deze aanbieding.
eBay-objectnummer:285606869451
Verzending en verwerking
Objectlocatie:
Riverside, California, Verenigde Staten
Wordt verzonden naar:
Afghanistan, Albanië, Algerije, Andorra, Angola, Anguilla, Antigua en Barbuda, Argentinië, Armenië, Aruba, Australië, Azerbeidzjan, Bahama's, Bahrein, Bangladesh, België, Belize, Benin, Bermuda, Bhutan, Bolivia, Bosnië en Herzegovina, Botswana, Brazilië, Brunei Darussalam, Bulgarije, Burkina Faso, Burundi, Cambodja, Canada, Centraal-Afrikaanse Republiek, Chili, China, Colombia, Costa Rica, Cyprus, Democratische Republiek Congo, Denemarken, Djibouti, Dominicaanse Republiek, Duitsland, Ecuador, Egypte, El Salvador, Equatoriaal-Guinea, Eritrea, Estland, Ethiopië, Fiji, Filipijnen, Finland, Frankrijk, Gabon, Gambia, Georgië, Ghana, Gibraltar, Grenada, Griekenland, Groenland, Guatemala, Guinee, Guinee-Bissau, Guyana, Haïti, Honduras, Hongarije, Hongkong, IJsland, Ierland, India, Indonesië, Israël, Italië, Ivoorkust, Jamaica, Japan, Jemen, Jordanië, Kaaimaneilanden, Kaapverdische eilanden, Kameroen, Kazachstan, Kenia, Kirgizië, Kiribati, Koeweit, Kroatië, Laos, Lesotho, Letland, Libanon, Liberia, Liechtenstein, Litouwen, Luxemburg, Macau, Macedonië, Madagaskar, Malawi, Maldiven, Maleisië, Mali, Malta, Marokko, Mauritanië, Mauritius, Mexico, Moldavië, Monaco, Mongolië, Montenegro, Montserrat, Mozambique, Namibië, Nauru, Nederland, Nepal, Nicaragua, Nieuw-Zeeland, Niger, Nigeria, Noorwegen, Oeganda, Oezbekistan, Oman, Oostenrijk, Pakistan, Panama, Papoea-Nieuw-Guinea, Paraguay, Peru, Polen, Portugal, Qatar, Republiek Congo, Roemenië, Rwanda, Saint Kitts en Nevis, Saint Lucia, Saint Vincent en de Grenadines, San Marino, Saudi-Arabië, Senegal, Servië, Seychellen, Sierra Leone, Singapore, Slovenië, Slowakije, Solomoneilanden, Spanje, Sri Lanka, Suriname, Swaziland, Tadzjikistan, Taiwan, Tanzania, Thailand, Togo, Tonga, Trinidad en Tobago, Tsjaad, Tsjechië, Tunesië, Turkije, Turkmenistan, Turks- en Caicoseilanden, Uruguay, Vanuatu, Vaticaanstad, Verenigd Koninkrijk, Verenigde Arabische Emiraten, Verenigde Staten, Vietnam, Wallis en Futuna, Westelijk Samoa, Zambia, Zimbabwe, Zuid-Afrika, Zuid-Korea, Zweden, Zwitserland
Uitgesloten:
Barbados, Frans-Guyana, Frans-Polynesië, Guadeloupe, Libië, Martinique, Nieuw-Caledonië, Oekraïne, Russische Federatie, Réunion, Venezuela
| Verzending en verwerking | Tot | Service | Levering*Zie opmerkingen over levering |
|---|---|---|---|
| US $4,99 (ongeveer EUR 4,59) | Verenigde Staten | Voordelige verzending (USPS Media MailTM) | Geschatte levering tussen ma, 10 jun en wo, 12 jun tot 43230 |
| US $8,99 (ongeveer EUR 8,27) | Verenigde Staten | Expresverzending (USPS Priority Mail®) | Geschatte levering tussen ma, 10 jun en wo, 12 jun tot 43230 |
| Verwerkingstijd |
|---|
| Wordt doorgaans binnen 1 werkdag na ontvangst van betaling verzonden. |
| Belasting |
|---|
| Verkoper berekent btw in |
Btw voor objectnr.285606869451
Btw voor objectnr.285606869451
Verkoper berekent btw op objecten die naar de volgende staten worden verzonden:
| Staat/provincie | Btw-tarief |
|---|---|
| American Samoa (AS) | 8.0% |
| Guam (GU) | 8.0% |
| Missouri (MO) | 8.0% |
| Northern Mariana Islands (MP) | 8.0% |
| Palau (PW) | 8.0% |
| Virgin Islands, U.S. (VI) | 8.0% |
Retourbeleid
| Nadat u het object hebt ontvangen, kunt u contact opnemen met de verkoper binnen | Terugbetaling wordt verstrekt als | Kosten voor retourzending |
|---|---|---|
| 30 dagen | Geld terug | Koper betaalt voor retourzending |
De koper is verantwoordelijk voor de kosten van de retourzending.
| Details retourbeleid |
|---|
| Retourzendingen geaccepteerd |
Betalingsgegevens
Betalingsmethoden
Ingeschreven als zakelijke verkoper
Feedback verkoper (4.177)
_***a (162)- Feedback gegeven door koper.
Afgelopen maand
Geverifieerde aankoop
Fast ship, great condition
a***y (1044)- Feedback gegeven door koper.
Afgelopen maand
Geverifieerde aankoop
Great seller
c***c (50)- Feedback gegeven door koper.
Afgelopen maand
Geverifieerde aankoop
Fantastic service. Book in perfect condition and I received book so fast. I would order from this seller again