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AAMI TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
Description: It relates them to the following existing standards, regulations, and guidance: • ISO 13485:2003, Quality management systems─Requirements for regulatory purposes • IEC 62304, Medical device software–Software lifecycle processes • ISO 14971:2007, Medical devices─Application of risk management to medical devices • FDA Code of Federal Regulations (CFR), Title 21, Part 820.30, Quality System Regulation: Design Controls– • FDA Guidance for the content of premarket submissions for software contained in medical devices • FDA General principles of software validation; Final guidance for industry and FDA staff Although this TIR does not provide a particular perspective for IEC TR 80002-1 (Guidance on the application of ISO 14971 for medical device software), the pertinent aspects of software risk management for medical devices were integrated throughout this TIR.
NAVY - SECNAV 4200.31C - (NAVCOMPT: NCB-6) ACQUIRING AND MANAGING CONSULTING SERVICES
Description: Does not apply to services supporting the Foreign Military Sales Program paid for with fund that will be reimbursed by the foreign customer or services citing other non-appropriated funds.
ARMY - AR 710-2 - SUPPLY POLICY BELOW THE NATIONAL LEVEL
Description: (13) Communications security (COMSEC) key software and publications, using AR 380-40 and TB 380-41. (14) Clothing sales stores operated under AR 700-84.
CRC - CIRCADIAN PHYSIOLOGY - CIRCADIAN PHYSIOLOGY - SECOND EDITION
Description: Preface It has been 6 years since the publication of the first edition of Circadian Physiology . Based on sales figures and comments from readers, it seems clear that the book achieved its goal of serving as a concise but rigorous review of basic and applied research on circadian rhythms.
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