How Long to Read Design Controls for the Medical Device Industry, Third Edition

How Long Does it Take to Read Design Controls for the Medical Device Industry, Third Edition?

It takes the average reader 3 hours and 8 minutes to read Design Controls for the Medical Device Industry, Third Edition by Marie B. Teixeira

Assuming a reading speed of 250 words per minute. Learn more

Description

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

How long is Design Controls for the Medical Device Industry, Third Edition?

Design Controls for the Medical Device Industry, Third Edition by Marie B. Teixeira is 185 pages long, and a total of 47,175 words.

This makes it 62% the length of the average book. It also has 58% more words than the average book.

How Long Does it Take to Read Design Controls for the Medical Device Industry, Third Edition Aloud?

The average oral reading speed is 183 words per minute. This means it takes 4 hours and 17 minutes to read Design Controls for the Medical Device Industry, Third Edition aloud.

What Reading Level is Design Controls for the Medical Device Industry, Third Edition?

Design Controls for the Medical Device Industry, Third Edition is suitable for students ages 10 and up.

Note that there may be other factors that effect this rating besides length that are not factored in on this page. This may include things like complex language or sensitive topics not suitable for students of certain ages.

When deciding what to show young students always use your best judgement and consult a professional.

Where Can I Buy Design Controls for the Medical Device Industry, Third Edition?

Design Controls for the Medical Device Industry, Third Edition by Marie B. Teixeira is sold by several retailers and bookshops. However, Read Time works with Amazon to provide an easier way to purchase books.

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