Software Development Standards - What's out there?

Atul Khandekar

Quite Involved in Discussions
#11
Originally posted by Andy Bassett
BTW Atul, i spent last Christmas in Kowalam Junction, Kerala. Had a very interesting relaxing time.
Ah, just missed you by about 750 miles!:cool:

Never been there myself.:( I understand Kowalam has some divine beaches and Kerala of course is called "God's Own Country".
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
H Standards Evolution regarding the Development, Supply, and Maintenance of Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Strategy for IEC62304 implementation half way into the software development process IEC 62304 - Medical Device Software Life Cycle Processes 9
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
O Software development plan : development methods IEC 62304 - Medical Device Software Life Cycle Processes 2
K Templates for software development quality audit Document Control Systems, Procedures, Forms and Templates 1
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1
R In a software development company: Is every bug reported by the customer a complaint? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
JoshuaFroud Design and Development of Software under 13485:2016 or 62304? ISO 13485:2016 - Medical Device Quality Management Systems 3
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
Y Application of IEC/EN 62304 at an advanced stage of software development IEC 62304 - Medical Device Software Life Cycle Processes 4
A Quality system vs SDLC (Software Development Life Cycle) (or ALM)? Other US Medical Device Regulations 2
Z Agile Software Development and 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I ISO 9001:2008 for Software Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Design and Development Outputs for Software Development (7.3.3) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Reusing existing RUO Software for IVD Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L AAMI TIR(SW1)/Agile Practices in the Development of Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
C Software Program Development GAMP Requirements Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P How to measure Software Development Measurement Uncertainty (MU) 16
P Environmental Aspects and Impacts while doing Software Development ISO 14001:2015 Specific Discussions 6
M Using a Kanban Lifecycle for the Software Development IEC 62304 - Medical Device Software Life Cycle Processes 8
J Software Development Process - How ISO9001 relates to Software Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q ISO 62304 (Medical Device Software Development) Verification Requirements IEC 62304 - Medical Device Software Life Cycle Processes 1
M Development of Medical Software for 510(k) - Where to start IEC 62304 - Medical Device Software Life Cycle Processes 10
michellemmm Software Product Development Quality Assurance (PDQA) Audit Checklists Software Quality Assurance 12
T Electronic Records and Software Development ISO 13485:2016 - Medical Device Quality Management Systems 7
T IEC 62304 & FDA: Software Development Methodologies for Class II- DICOM device IEC 62304 - Medical Device Software Life Cycle Processes 8
D Info for Health and Safety in Software Development companies Occupational Health & Safety Management Standards 6
L IT - Software Development SOPs (Standard Operating Procedures) Software Quality Assurance 3
M Software Development Certification - Development and Analysis Tools Other ISO and International Standards and European Regulations 3
K Medical Device Software Development Procedure IEC 62304 - Medical Device Software Life Cycle Processes 20
L Software Development and Validation SOPs Software Quality Assurance 14
C Control of the Development and Test Environment - Software for Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 2
U Recognised Methodology for Monitoring Software Development Performance Software Quality Assurance 1
J How to address Clause 7.6 for a software development organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Design Review OR Design Change - Software development company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G MRM (Management Review) Inputs Sheet Format for a Software Development Company Management Review Meetings and related Processes 1
P Software to help meet ISO & AS9100 Design & Development Rqmts Design and Development of Products and Processes 2
K Off-the-shelf Software Environment for Software development Software Quality Assurance 6
Q Software/Tools to Manage ISO 12207 Audit of Software Development Process Software Quality Assurance 4
A IEC 62304 Software Development Plan IEC 62304 - Medical Device Software Life Cycle Processes 28
W Software development company for Medical Device Diagnostic Equipment ISO 13485:2016 - Medical Device Quality Management Systems 5
T Internal audit checklists related to the software development process Internal Auditing 3
L Software and Web Site Development - Need help with interpreting 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H IT Software Life Cycle Development - How do 7.3.2 to 7.3.4 apply? Software Quality Assurance 4
P How Backward Traceability is maintained in Software Development? Software Quality Assurance 1
H Software Life Cycle - Software Development Procedure Software Quality Assurance 2
Similar threads


















































Top Bottom