Significant and Nonsignificant Risk Medical Device Handbook
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Add to basketDieser 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.
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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.
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)
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Instructions for revocation/
Standard Business Terms and customer information/ data protection declaration
Revocation right for consumers
(A ?consumer? is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)
Instructions for revocation
Revocation right
You have the right to revoke this contract within one month without specifying any reasons.
The revocation period is one month...
Instructions for revocation/
Standard Business Terms and customer information/ data protection declaration
Revocation right for consumers
(A ‘consumer’ is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)
Instructions for revocation
Revocation right
You have the right to revoke this contract within one month without specifying any reasons.
The revocation period is one month with effect from the day,
on which you or a third party nominated by you, which is not the carrier, had taken possession of the products, provided you had ordered one or more products within the scope of a standard order and this/these product/products is/are delivered uniformly;
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last product, provided you had ordered several products within the scope of a standard order and these products are delivered separately;
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last part delivery or the last unit, provided you had ordered a product, which is delivered in several part deliveries or units;
In order to exercise your revocation right, you must inform us (Moluna GmbH, Münsterstr. 105, 48268 Greven, Telephone number: 02571/5 69 89 33, Fax number: 02571/5 69 89 30, E-Mail address: abe@moluna.de) of your decision to revoke this contract by means of a clear declaration (e.g. a letter sent via post, fax or email). You can use the enclosed specimen revocation form for this, which however is not mandatory.
In order to safeguard the revocation period, it is sufficient that you send the notification about the exercise of the revocation right before the expiry of the revocation period.
Consequences of the revocation
If you revoke this contract, we shall repay all the payments, which we received from you, including the delivery costs (with the exception of additional costs, which arise from that fact that you selected a form of delivery other than the most reasonable standard delivery offered by us), immediately and at the latest within 14 days from the day on which we received the notification about the revocation of this contract from you. We use the same means of payment, which you had originally used during the original transaction, for this repayment unless expressly agreed otherwise with you; you will not be charged any fees owing to this repayment.
We can refuse the repayment until the products are returned to us or until you have furnished evidence that you have sent the products back to us, depending on whichever is earlier.
You must return or transfer the products to us immediately and, in any case, at the latest within 14 days with effect from the day on which you inform us of the revocation of this contract. The deadline is maintained if you send the products before the expiry of the 14 day deadline.
You bear the direct costs for returning the products.
You must pay for any depreciation of the products only if this depreciation can be attributed to any handling with you that was not necessary for checking the condition, features and functionality of the products.
Criteria for exclusion or expiry
The revocation right is not available for contracts
for delivery of products, which are not prefabricated and for whose manufacturing an individual selection or stipulation by the consumer is important or which are clearly tailored to the personal requirements of the consumer;
for delivery of products, which can spoil quickly or whose use-by date would be exceeded quickly;
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The revocation right expires prematurely in case of contracts
for delivery of sealed products, which are not suitable for return for reasons of health protection or hygiene if their seal has been removed after the delivery;
for delivery of products if they have been mixed inseparably with other goods after the delivery, owing to their condition;
for delivery of sound or video recording or computer software in a sealed package if the seal has been removed after the delivery.
Specimen - revocation form
(If you wish to revoke the contract, please fill up this form and send it back to us.)
To Moluna GmbH, Engberdingdamm 27, 48268 Greven, Fax number: 02571/5 69 89 30, Email address: abe@moluna.de :
I/we () herewith revoke the contract concluded by me/ us () regarding the purchase of the following products ()/
the provision of the following service ()
Ordered on ()/ received on ()
Name of the consumer(s)
Address of the consumer(s)
Signature of the consumer(s) (only in case of a notification on paper)
Date
(*) Cross out the incorrect option.
II. Kundeninformationen
Moluna GmbH
Engberdingdamm 27
48268 Greven
Deutschland
Telefon: 02571/5698933
E-Mail: abe@moluna.de
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letzte Aktualisierung: 23.10.2019
| Order quantity | 26 to 60 business days | 26 to 60 business days |
|---|---|---|
| First item | £ 43.15 | £ 43.15 |
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