Standard Operating Procedures (SOP)  

FORM Sample

Design and Development Plan (DDP) Template

ID Task Name Duration Start Finish
1 Design and Development Plan (DDP) [820.30(b)] xx days    
2 Responsibility for Generating / Writing DDP xx days    
3 Responsibility for Reviewing DDP xx days    
4 Responsibility for Approving DDP xx days    
5 Design and Development Plan Complete xx days    
6 Responsibility for modifying DDP (if needed) xx days    
7 Responsibility for ensuring compliance to DDP xx days    
8 Define overall responsibility for Design Review(s) Coordination G xx days    
9 Define overall responsibility for Design Verification Coordination G xx days    
10 Define overall responsibility for Design Validation Coordination IS, G xx days    
11 General [820.30(a)] IS xx days    
12 Reference procedure(s) xx days    
13 Assessing New Product Ideas __________ G xx days    
14 Training and retraining of design managers and design staff __________ G xx days    
15 Use of Consultants __________ G xx days    
16 Evaluation of the design process __________ G xx days    
17 Product evaluation, including third party product certification and approvals __________ G xx days    
18 Patenting or other means of design protections __________ G xx days    
19 Goals and Objectives G xx days    
20 Check what is to be developed G xx days    
21 ___ Hardware (Catalog # _____ Revision _____) G xx days    
22 ___ Software (Catalog # _____ Version _____) G xx days    
23 ___ Services (Catalog # _____ Revision _____) G xx days    
24 ___ Processed Materials (Catalog # _____ Revision _____) G xx days    
25 ___ Manufacturing Processes (Catalog # _____ Revision _____) G xx days    
26 ___ Quality System Equipment (Catalog # _____ Revision _____) xx days    
27 Submission Requirements xx days    
28 ___ Check if new submission required, Reference # __ xx days    
29 ___ Check if Letter to File required, Reference # __ xx days    
30 ___ Check if no regulatory action required (exempt) xx days    
31 Reference original 510(k) Number ______________ xx days    
32 Reference original PMA Number _________________ xx days    
33 Check device classification R xx days    
34 ____ Check if class I R xx days    
35 ____ Check if device is automated with computer software R xx days    
36 ____ Check if class II R xx days    
37 ____ Check if class III R xx days    
38 ____ Check if exempt from Design Controls xx days    
39 State rationale, Reference # ___ xx days    
40 Design Control Product Overview xx days    
41 ____ Check if original design (including any changes after 6/1/97) IS xx days    
42 If initiated prior to 6/1/97, state date design effort was initiated ________ IS xx days    
43 ____ Check if modification to existing design (any changes after 6/1/97) IS xx days    
44 If initiated prior to 6/1/97, state date design effort was initiated __________ IS xx days    
45 Identify at what stage in the design & development effort design controls were applied ___________ IS xx days    

Copyright SQM, Inc., 1998 - 2001.  All Rights Reserved.                                      Page 1 of 90

 

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Software Quality Management, Inc. (SQM), 2 Southerly Court, Suite 603, Towson, MD, 21286, USA, 410-339-5307 (v), 

410-823-8019 (f), info@sqminc.com, copyright SQM, 1997-2002, Last modified: November 18, 2009