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ASQ - CAPA FDA-REG IND - CAPA FOR THE FDA-REGULATED INDUSTRY Organization: ASQ
Date: 2011-01-01
Description: Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions.
AAMI TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2012-01-01
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 devicesFDA 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.
SEPT - IEC 62304 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARE – SOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40 Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis. With a strong reference for using ISO 14971 processes 3.
SEPT - IEC 62304 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARE – SOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis. With a strong reference for using ISO 14971 processes 3.

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