This

 table  illustrates  the  relationship  between  the  FDA  Design  Control  elements,  IEC62304,  ISO13485:2016  and  lists  
typical  deliverables  
 
 
FDA  Design  Control  
IEC  62304     ISO13485:2016   Typical  Deliverables  
Element  
7.1  Planning  of  product  realization  
Design  and   5.1  Software  Development  
7.3.2  Design  and  Development   •   Project  Plan  (Software  Development  Plan).    
Development  Planning   Plan  
Planning  
7.2.1  Determination  of  requirements  
related  to  product  
5.2  SW  Requirements   •   Product  Requirements  Document  
Design  Input   7.2.2  Review  of  requirements  related  
Analysis   •   Software  Requirements  Specification.    
to  product  
7.3.3  Design  and  Development  Inputs  
•   Software  Design  Specifications  and  
5.3  SW  Architecture  
Descriptions    
5.4  SW  Detailed  Design  
Design  Output   7.3.4  Design  and  Development  Outputs   •   Device  Labeling  (e.g.  Instructions  for  use,  
5.5  SW  Unit  
help  files)  
Implementation  
•   Source  Code  
•   Technical  design  reviews.    
5.5  SW  Unit  
•   Code  reviews  
Design  Review   implementation  and   7.3.5  Design  and  Development  Review  
•   Document  reviews  
verification  
•   Milestone  reviews    
5.5  SW  Unit  
Implementation  and   •   Test  Plan  and/or  Protocol    
7.3.6  Design  and  Development  
Design  Verification   Verification   •   Verification  Results  and  Reports    
Verification  
5.6  SW  Integration  and   •   Traceability  analysis    
integration  Testing  
•   Validation  Plans,  Method(s)  and  Protocol(s);  
5.7  Software  System   7.3.7  Design  and  Development  
Design  Validation   •   Validation  Reports    
Testing   Validation  
•   Usability/  User  Testing  Report  
•   Deployment  (Design  Transfer)  Record  
Design  Transfer   5.8  Software  Release   7.3.8  Design  and  Development  Transfer  
•   Final  Build,  Build  Procedure.  
6  Software  Maintenance  
Design  Changes   7.3.9  Design  and  Development  Changes   •   Design  Change  Record.    
Process  
8  SW  Configuration  
Design  History  File   7.3.10  Design  and  Development  Files   •   Design  File  Index    
Management  
•   Risk  Management  Plan.  
7.1  Planning  of  product  realization  
7  Software  Risk   •   Risk  Assessment;  
Risk  Management   7.3.3  Design  and  Development  Inputs  
Management   •   Risk  Report  
7.3.9  Design  and  Development  Changes  
•   Post-­‐market  Risk  Assessment  
 

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