Design Controls for the Medical Device Industry Third Edition ebook
$24.80
Order Processing Time
All orders placed on our website are processed within 2-4 business days, from Monday to Friday, 8:00 AM – 6:00 PM Pacific Time (PT). Orders received after our daily cut-off time of 10:00 PM PT will be processed on the next business day. Please note that we do not process orders on weekends or public holidays.
Shipping Methods and Carriers
Zetlly partners exclusively with reputable shipping carriers to ensure timely delivery of your orders. We utilize:
-
FedEx
-
UPS
-
USPS
The choice of carrier is determined by factors such as destination, weight, and delivery timeframe to provide optimal service.
Shipping Rates and Fees
-
Free shipping is provided for all orders over $199.
-
Orders under $199 will incur a flat-rate shipping fee of $7.99.
-
All orders shipped within the United States will be subject to a sales tax charge of 5%.
Estimated Delivery Time
Once shipped, orders typically arrive within 6 to 10 business days. Our delivery times are from Monday to Friday, 8:00 AM – 6:00 PM Pacific Time (PT). Please allow additional time for deliveries to remote or rural locations.
Shipping Restrictions
Zetlly currently ships exclusively within the United States. At present, we do not offer international shipping or deliveries to P.O. boxes or APO/FPO addresses. Orders placed with addresses outside our designated delivery areas will be canceled, and refunds will be processed accordingly.
Tracking Your Order
Upon shipment, customers will receive a confirmation email containing tracking information. You can track your order directly through the provided tracking link or by visiting the carrier’s official website:
Please allow up to 48 hours for tracking information to update in the carrier’s system.
Eligibility for Returns and Exchanges
We accept returns and exchanges within 30 days from the date your order is delivered. Items must be unused, in the original condition, and accompanied by the original packaging and receipt or proof of purchase.
How to Return or Exchange an Item
To initiate a return or exchange, please follow these steps:
-
Contact our customer support at [email protected] with your order number and reason for return or exchange.
-
Our team will respond within 24 hours to provide detailed instructions, including the specific Return Address for your shipment.
-
Package your item securely and include all original packaging and proof of purchase.
Return shipments should be sent to: Blanq LLC 1201 South Hope Street Apt 2413, Los Angeles, CA 90015, USA
Return Conditions
-
Items must be returned in their original condition, unworn, undamaged, and complete with all original packaging and documentation.
-
Items returned without prior authorization or not meeting the above conditions may not qualify for a refund or exchange.
Return Shipping Costs
Customers are responsible for return shipping costs unless the return is due to our error or a defective product. We recommend using a trackable shipping service to ensure your return reaches us safely.
Non-Returnable Items
The following items cannot be returned:
-
Digital products (e-books or downloadable content)
-
Personalized or customized items
-
Gift cards
Accepted Payment Methods
Zetlly accepts the following secure and widely trusted payment options:
-
PayPal: Easily pay through your PayPal account, benefiting from secure transactions and buyer protection.
-
Stripe: Pay securely using major credit and debit cards including Visa, MasterCard, American Express, and Discover via Stripe’s encrypted payment gateway.
Payment Security
At Zetlly, your security is our utmost priority. We utilize advanced encryption technologies and robust security protocols provided by PayPal and Stripe. All payment information entered on our site is encrypted using Secure Socket Layer (SSL) technology, ensuring your financial information remains private and secure throughout the transaction process.
Zetlly does not store any credit card or sensitive financial information directly on our servers, further enhancing the security and protection of your personal data.
Payment Process and Confirmation
Upon placing an order, your chosen payment method (PayPal or Stripe) will immediately process the transaction. You will receive an automated confirmation email shortly after your payment has been successfully completed, detailing your transaction and order summary.
Please retain this confirmation email for your records and reference in case of any inquiries or disputes.
This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company’s design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today’s Notified Body Auditors’ and FDA Investigators’ expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements Additional ISBNs9780815365525|9781351261487, 0815365527|1351261487Design Controls for the Medical Device Industry, Third Edition 3rd Edition by Marie B. Teixeira and Publisher CRC Press. ISBN: 9781351261463, 1351261460. The print version of this textbook is ISBN: 9780815365525, 0815365527.
Related products
New Book