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After thousands of training hours in the Medical Device industry, Anna Lundén has earned a good understanding for what kind of GMP/QSR knowledge that is requested, both for the employees in this industry as well as for people in adjacent companies as suppliers, consultants and contractors.
Now Anna Lundén have gathered the most important facts in this book:
• Basic knowledge about Quality Systems in the Medical Device industry in a clear and easy to read style
• Comparison of similarities and differences in requirements and terminology in ISO 13485 and US QSR (21 CFR 820)
• Tables with specific references to requirements in ISO 13485 and 21 CFR 820
• Suitable for self studies and to note references to one’s own activities
Author: Anna Lundén
Pages: 122
Language: English
Publisher: Key2Compliance AB
Published: March 18, 2020
Edition: 4
ISBN: 978-91-983174-7-3
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