Significant and Nonsignificant Risk Medical Devices
Language: English
Published by Springer, Springer Aug 2025, 2025
- Softcover
- New
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.
AbeBooks seller since January 11, 2012
Condition: New
£ 73.94
Quantity: 2 available
Add to basketItem description from seller
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. 444 pp. Englisch.…
Seller Inventory # 9783031528408
- Title
- Significant and Nonsignificant Risk Medical Devices
- Author
- Prakash Srinivasan Timiri Shanmugam
- Publisher
- Springer, Springer Aug 2025
- Publication year
- 2025
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 3031528409
- ISBN 13
- 9783031528408
- Item weight
- 668 grams
- Dimensions
- 235x155x24 mm
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.
"Synopsis" may belong to another edition of this title.
About the Author
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 Shanmugam has an MS and a Ph.D. in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras and completed his postdoctoral research at Tulane University and LSU Health Shreveport, Louisiana. He is the editor of five books, including the Medical Device Guidelines and Regulations Handbook (Springer, 2022), and the author of several book chapters. He has published research articles in various peer-reviewed international journals and conference proceedings/abstracts.
Thangaraju Pugazhenthan, MBBS, MD, DNB, MNAMS, PG.Diploma in Diabetology, is an assistant professor in the Department of Pharmacology at All India Institute of Medical Sciences (AIIMS),Raipur. Additionally he hold the Master of Business Administration, MBA (Hospital management). He previously worked in Central Health Services at the Central Leprosy Teaching and Research Institute. He received an MBBS from Madurai Medical College and did his post-graduate training at the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. He is the member of world association of medical editors (WAME). He has published more than 140 internationally indexed publications, including in The Lancet and The BMJ. He is co-editor of the book Medical Device Guidelines and Regulations Handbook (Springer, 2022), author of the books Newer Pharmacological Concepts of Managing Erythema Nodosum Leprosum (Lambert, 2017) and A Pharmacological Guide to Non-Steroidal Anti-Inflammatory Medications (Nova Science Publishers, 2021), and a contributing chapter author for the books Ophthalmology and Otorhinolaryngology in Toxicological Aspects of Medical Device Implants (Elsevier, 2020) and Leprosy: From Diagnosis to Treatment (Nova Science Publishers, 2020). He is the youngest to be elected as Fellow of Royal college of Physician, FRCP (London). He is also the Fellow of international medical sciences academy, (FIMSA).
Dr Indumathy Jagadeeswaran, PhD, is currently working as a Senior Research Associate with the Department of Pediatrics at UT Southwestern Medical Center, Dallas, Texas. She has been working in the field of physiology for over a decade. Dr. Jagadeeswaran has an M.S. in Biotechnology with Biochemistry (interdisciplinary) and a Ph.D. in Medical Physiology from the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Pondicherry, India. She has editorial experience as an associate editor for a peer-reviewed international journal and is presently a peer-review member of the Scientific Committee and Society. She has published several research articles in peer-reviewed international journals and is a co-author of the book Biocompatibility Protocols for Medical Devices and Materials (Elsevier, 2022)
"About the title" may belong to another edition of this title.
BuchWeltWeit Ludwig Meier e.K.
Bergisch Gladbach, Germany
AbeBooks seller since January 11, 2012
Shipping rates from Germany to U.S.A.
| Item | 5 to 15 business days | 5 to 15 business days |
|---|---|---|
| First item | £ 19.29 | £ 19.29 |
Payment methods
- Bank Wire Transfer
- Check
- Paypal
Seller's business information
BuchWeltWeit Ludwig Meier e.K.
Germany
Terms of sale
BuchWeltWeit Inh. Ludwig Meier e.K.
Inhaber: Ludwig Meier
De-Gasperi-Str. 8
51469 Bergisch Gladbach
Deutschland
Tel.: +49(0)22028659300
Fax: +49(0)22028659301
E-Mail: info@buchweltweit.de
Registergericht: Amtsgericht Köln
Registernummer: HRA 28253
Umsatzsteuer-Identifikationsnummer: DE815259907
Wir sind zur Teilnahme an einem Streitbeilegungsverfahren vor einer Verbraucherschlichtungsstelle weder verpflichtet noch bereit.
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
Der Versand ins Ausland findet IMMER mit DHL statt. Auch nach Österreich verschicken wir nur mit DHL! Daher Standardversand == Luftpost!