Medical Device Regulatory Practices: An International Perspective Theisz, Val
Language: English
Published by Jenny Stanford Publishing, 2015
- Hardcover
- Used
Seller: online-buch-de, Dozwil, Switzerlandonline-buch-de
AbeBooks seller since April 4, 2011
Condition: Used - As new
£ 78.77
Quantity: 1 available
Add to basketItem description from seller
Seller Inventory # 87-5-126
- Title
- Medical Device Regulatory Practices: An International Perspective Theisz, Val
- Author
- Theisz, Val
- Publisher
- Jenny Stanford Publishing
- Publication year
- 2015
- Condition
- gebraucht; wie neu
- Binding
- Hardcover Aug 03, 2015
- Language
- English
- ISBN 10
- 9814669105
- ISBN 13
- 9789814669108
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.
"Synopsis" may belong to another edition of this title.
About the Author
Val Theisz is a regulatory professional with over 15 years’ experience in medical device regulations, of which she spent 8 in leadership roles in regulatory affairs, regulatory operations, and quality assurance. She holds a masters degree in electrical engineering from the Polytechnic University of Timişoara, Romania, and a Regulatory Affairs Certification (RAC) for European and US regulations from the Regulatory Affairs Professionals Society (RAPS). Val has been a RAPS fellow since 2010.
Working on both sides of the regulatory divide―as a reviewer and quality systems auditor (7 years) and in roles with responsibility for obtaining regulatory approvals and maintaining regulatory compliance (10 years)―enabled Val to gain an in-depth understanding of the typical challenges facing medical device companies. One of her achievements was obtaining the CE marking approval for a life-sustaining active implantable medical device within six months from the date of submission. During a five-year stint as regulatory operations manager with one of the largest pharmaceutical companies, Val implemented electronic data management systems for a large product portfolio and learned about process improvement techniques.
"About the title" may belong to another edition of this title.
online-buch-de
Dozwil, Switzerland
AbeBooks seller since April 4, 2011
Shipping rates from Switzerland to U.S.A.
| Item | 7 to 14 business days | 8 to 15 business days |
|---|---|---|
| First item | £ 30.93 | £ 30.93 |
Payment methods
- Paypal
Store description
Seller's business information
Biopuls GmbH
Amriswilerstrasse 10, Biopuls GmbH
Dozwil, Switzerland 8582
Terms of sale
Die Bücher werden in der Regel bis 48 Stunden nach
Bestelleingang verschickt. Die Versandkostenpauschalen basieren auf Durchschnittswerten für unter 1 kg schwere Bücher. Versand in einem
Luftpolster- oder Kartonumschlag.
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 online-buch-de, Dozwil, Switzerland, +41 079-4124641, 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
Die Ware wird in der Regel innerhalb von 48 Stunden nach Bestelleingang verschickt. Bitte entnehmen Sie den voraussichtlichen Liefertermin Ihrer Bestellbestätigung. Die Versandkostenpauschalen basieren auf Durchschnittswerten für 1 kg schwere Bücher. Über abweichende Kosten (z.B. wegen eines sehr schweren Buches) werden Sie gegebenenfalls vom Verkäufer informiert.