This essential reference 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.
Medical Device Quality Assurance and Regulatory Compliance
summarizes regulation activities of the FDA, the European Economic Community, and the Global
Harmonization Task Force
shows how to choose a standard from the ISO 9000 and ISO 14000 series
teaches how to prepare your company for auditing, how to choose a notified body, and how to
survive the audit
reviews standards dealing specifically with medical devices such as EN 46000, ISO 13485, and ISO
13488
discusses the requirements for product submittals prior to product introduction
addresses current issues such as third party approvals
and more!
Including numerous key references, tables, and drawings, Medical Device Quality Assurance and
Regulatory Compliance is ideal for biomedical, quality assurance, reliability, software, product design,
manufacturing, research and development, and industrial engineers; project managers; biomedical
technicians; medical device purchasing personnel; and upper-level undergraduate and graduate students in
these disciplines.
| ISBN(s) : | 0824701771 |
| Number of Pages : | 504 |
| Published : | 08/01/1998 |
