Responsibility sharing matrix


You may be confused, even though you appoint a consultant, who is doing what? How to do? What we should do? Please read the below table for your information.

 

SL NO DESCRIPTION OF ACTIVITY CLIENT CONSULTANT
01 Description of the Device As to be provided as per Consultant instruction  
02 Intended use of the device To be provided as per Consultant instruction  
03 Device models & Specification To be provided as per Consultant instruction  
04 Mechanism of action To be provided as per Consultant instruction  
05 Classification and justification of Medical Device   Consultant will provide
06 List of Applicable Directives   Consultant will provide
07 List of Applicable MDD Guidelines followed   Consultant will provide
08 List of Applicable Harmonized Standards Client has to provide after taking advice from consultant  
09 List of Applicable Non-Harmonized Standards Client has to provide after taking advice from consultant  
10 Declaration of Conformity   Consultant will Draft
11 Use of Animal Origin products   Consultant will provide
12 Use of Blood or Blood Components   Consultant will provide
13 Integration of a Medicinal Product into the Device   Consultant will provide
14 Product Design documents Client has to provide as per ISO 13485 Consultant will review and guide wherevernecessary
15 Connection to other Devices Client has to provide  
16 Phthalates Free Declaration   Consultant will provide
17 EC Representative Client has to organize Consultant will draft if required.
18 Essential Requirement Checklist   Consultant will provide
19 Risk Analysis As per ISO 13485 and EN ISO 14971:2007 Client has to provide Consultant will review, modify according to NB
requirements
20 Clinical Evaluation   Consultant will provide
21 Description of Manufacturing Client has to provide  
22 Critical process & MSDS Client has to provide Consultant will guide and review thedocuments
23 Description about critical suppliers and their quality certificates Client has to provide  
24 Environmental controls To be provided as per Consultant instruction Consultant will guide and review thedocuments
25 Pre-clinical testing To be provided as per Consultant instruction Consultant will guide and review thedocuments
26 In-House test reports To be provided as per Consultant instruction  
27 Bill of materials Client has to provide  
28 Device shelf life Client has to conduct the study report Consultants will provide guidance
29 Biocompatibility Client has to organize the report Standard Identification by consultant
30 Electrical safety Client has to organize the report Standard Identification by consultant
31 Product Specific Standards Client has to provide  
32 Usability To be provided as per Consultant instruction Consultant will guide and review thedocuments
33 Software validation To be provided as per Consultant instruction  
34 Sterilization To be provided as per Consultant instruction Consultant will guide and review thedocuments
      35 Quality Controls Client has to provide documents as per consultant instructions  
36 Device Labelling Client has to provide documents as per consultant instructions  
37 Device Packing Client has to provide documents as per consultant instructions  
38 Storage and Transportation Client has to provide documents as per consultant instructions  
39 Packaging validation Client has to provide documents as per consultant instructions Consultant will guide and review thedocuments
40 Lifetime of the device Client has to provide documents as per consultant instructions Consultant will guide and review thedocuments
41 Post Manufacturing Activities   Consultant will prepare related procedures &relevant templets as per ISO 13485