Medical Device Quality Assurance and Regulatory Compliance

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

List of contents

Background of standards and regulations: quality assurance and regulatory compliance; the FDA; the European Union; the global harmonization task force; software as a special case. Quality systems: the ISO 9000 series of standards; ISO 9000 requirements/ compliance; the ISO 14000 standard; ISO 14000 requirements/compliance. Quality devices: the EN46001 standard; EN46001 requirements/compliance; the ISO 13485 standard; ISO 13485 requirements/ compliance; IEC 601-1-4; IEC601-1-4 requirements/compliance; ISO 9000-3; ISO 9000-3 requirements/compliance; IEC601-1; IEC601-1 requirements/compliance. Regulation: the medical device directives; medical device directive requirements/compliance; the quality system regulations (QSR); QSR requirements/compliance. Appendices: addresses of standards organizations; addresses of registrars notified bodies; addresses of regulatory agencies; addresses of FDA offices; addresses of consulting training organizations; addresses of testing organizations. Glossary.

About the author

Fries, Richard C.

Summary

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Product details

• Authors: Richard C Fries, Richard C. Fries, Richard C. (Isorel Fries, Fries Richard C.
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Paperback / Softback
• Released: 31.08.2019
• EAN: 9780367400361
• ISBN: 978-0-367-40036-1
• No. of pages: 496
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Clinical medicine; MEDICAL / Biotechnology, TECHNOLOGY & ENGINEERING / Biomedical, environmental science, engineering & technology, Life sciences: general issues, Materials science, Biomedical engineering, Environmental science, engineering and technology, Educational: Sciences, General Science, TECHNOLOGY & ENGINEERING / Materials Science / General