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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: The following groups are the intended audience for this TIR: • Medical device manufacturers who are planning to use AGILE techniques • Manufacturers who are currently practicing AGILE and are entering the regulated medical device space • Software development teams, including software test and quality groups • Software definers, including marketing, sales, and other representatives of the customer • Senior management, project managers, quality managers • Quality systems and regulatory affairs personnel • Internal and external auditors • Regulating bodies, agencies, and organizations responsible for overseeing the safety and effectiveness of medical devices Exclusions This TIR is not intended to be used as an educational tool or tutorial for the following: • AGILE development practice • Quality system regulations This TIR should be regarded as a reference and as a guidance intended to provide recommendations for complying with international standards and FDA guidance documents when using AGILE practices in the development of medical device software.
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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