BIORAD MEDISYS PVT.

LTD, PUNE

Title : Design Validation Doc. No :- 504-DVL-XXX-00

Project Name Eg : Multiband Ligator and Kit

Date of Validation
KOL (Key Opinion Leader) Dr. Amol Bapaye, Deenanath Mangeshkar Hospital,Pune.

LIST OF APPLICABLE INSTRUMENTS AND STANDARDS

Device to be evaluated Eg : Multiband ligator
Accessories & Standard
items
List of compatible
instruments

METHODDOLOGY
Tick the
USERS
correct option
KOL and/or Surgeon(s) will be explained the Instructions
for use and accordingly he/she will perform the surgical
Actual user
steps. All activities should be recorded through
Audio/Visual tools.
Pseudo Participants/Volunteers who are not part of the
project team shall be instructed to play a role in the
Simulated User
simulated test. The role could be that of a Surgeon, Asst
surgeon, Staff, Cleaning Staff.
Tick the
TEST ENVIRONMENT
correct option
Dry Lab Tabletop dry models may be used
Wet Lab Animal or tissue model may be used

Rating Rationale:

1 = Does not meet the requirement

3 = Somewhat meets the requirement

5 = Meets the requirements but needs improvement

7 = Just Satisfied with the requirements

9 = Highly Satisfied with the requirements

Form No:- BRP/DEF/001/06/03 Unauthorized Copying Prohibited Page 1of4

 BIORAD MEDISYS PVT. LTD, PUNE

Title : Design Validation Report Doc. No :- 504-DVAL-XXX-00

Validation
DRS ID Requirements Features Function Remarks
1 3 5 7 9
Functional Requirements
Eg : How satisfied are you
1 with the performance of
the device ?

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 BIORAD MEDISYS PVT. LTD, PUNE

Title : Design Validation Report Doc. No :- 504-DVAL-XXX-00

Acceptance Criteria:

1. All must have requirements shall score at least 5 and above.

2. All nice to have requirements shall be evaluated by marketing based on market insights.

SUMMARY OF VALIDATION
Must have Requirements
Requirements accepted by the surgeon Requirements not accepted by the surgeon and reasons thereof

Nice to have Requirements

Requirements accepted by the surgeon Requirements not accepted by the surgeon and reasons thereof

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 BIORAD MEDISYS PVT. LTD, PUNE

Title : Design Validation Report Doc. No :- 504-DVAL-XXX-00

ADDITIONAL REMARKS / SUGGESTIONS

SIGNATURE :- DATE :-

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