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Guides and Tools for Development and compliance with Quality Management Systems and Software Engineering
 

   
For i
mplementation of Quality System Standards
   
ISO 9001:2015 ISO/TS 16949:2009   
       
   
-  Requirements
-  Development 
-  Implementation
   
-  Requirements
-  Development 
-  Implementation
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For Medical Device Firms

   
Checklists for compliance with the following new software standards 

IEC 62304 and ISO 13485:2015

Below are the key checklists for compliance with the major software
"Medical Device" standards 
       

     
 
New 
IEC 62304:2015 Checklist

This Checklist is for the application of the medial device Standard IEC 62304:2015 Medical Device Software – Software Life Cycle Processes -  including Amendment 1. This checklist defines clearly the .............
     

New
ISO 13485:20016 Software Requirements

Checklist for ISO 13485:2016 Medical devices - Quality management systems- Requirements for software related regulatory purposes. Being a “stand-alone” quality system standard for medical ...........      
   
Checklist for FDA “General Principles of Software Validation”

Evidence product checklist for the FDA document “General Principles of Software Validation” - Final Guidance for Industry and FDA staff. The checklist uses a classification scheme of physical evidence comprised of procedures, plans ............
   
FDA Guide, Pre-market Submissions, Software in Medical Devices
This is a Checklist for the application and compliance with the document FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices’. This is a “must have” for all quality managers  ..........
   
FDA Off-the-Shelf Software in Medical Devices, Checklist

This new edition of the checklist has been updated to reflect the suggested compliance with the document ”Compliance on Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software" ........
   
ANSI/UL 1998:2004 Checklist
This checklist was updated to include Revision 1 of this major software engineering document "ANSI/UL 1998 Standard for Software in Programmable Components". This standard is used by the ............      

   
ISO/IEC 90003:2014 Checklist

Checklist for the software engineering quality standard: “ISO/IEC 90003:2014; Software engineering - Guidelines for the application of ISO 9001:2008 to computer software”. The Checklist uses a classification scheme .........
   
ISO 9001:2015 Evidence Product Checklist
Checklist for the standard ISO 9001:2015  Quality Management System Requirements. The 2015 version of ISO 9001 has proved to be a landmark quality standard for the international business community ............
      
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Data Security

To protect your company  and customers it is important to meet the requirements of the  International 
Data Security Standards
  
Below are the links to  3 checklists that will help you to meet this goal:
ISO/IEC 27018:2014 Checklist
for protection of information security

 

ISO/IEC 27001:2013 Checklist
for information and
data requirements 
   
ISO/IEC 27002:2013 Checklist
for information and data management
   
   
  
   
Other popular checklists for International Standards    
     
ANSI/UL 1998:2004 Checklist
Checklist for requirements, development and compliance of software in programmable component
 
      
ISO/IEC /IEEE 42010:2011
Checklist  for development and compliance of Systems and Software Engineering Architecture
 
         
Templates for Software Configuration Management and Maintenance
For standards such as  ISO/IEC 12207, ISO/IEC 15288, IEC 62304, IEEE 14764, ANSI/EIA-649-B, etc.
 
         
ISO/IEC 20000-1:2011 
Information Technology

Evidence Product Checklist for Information Technology - Service Management - Service management system requirements
 

    

 




   
   
  
 

 

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