Design and Development Plan for a Medical Device - Template needed

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bio_subbu

Super Moderator
#3
Can anyone provide a template for Design and Development Plan for a medical device?
There is no specific requirement for template on design plan, but the plan should include the following details:

Description of the goals and objectives of the design and development program; i.e., what is to be developed.

Delineation of organizational responsibilities with respect to assuring quality during the design and development phase, to include interface with any contractors;

Identification of the major tasks to be undertaken, deliverables for each task, and individual or organizational responsibilities (staff and resources) for completing each task;

Scheduling of major tasks to meet overall program time constraints;

Identification of major reviews and decision points;

Selection of reviewers, the composition of review teams, and procedures to be followed by reviewers;

Controls for design documentation & Notification activities

For more details refer FDA guidance document “Design control guidance for medical device manufacturers” section B (Design and development planning)

Regards
S. Subramaniam
 
I

itay26

#4
Halo
I do not have any templates but I can direct you to an article specifying the requirements on 13485quality.com. Just click Design and Development on the main menu.
Hope it is helpful.
 
A

ambala

#5
Hello we are in the initial phase of designing a medical product. can anyone help me by providing templates for product deliverables checklist,problem solving form and flow chart,configuration record etc
 
S

Scogs

#6
Question for you all: the QSR states that "the plans shall be reviewed, updated and approved as the design and development evolves."

Is this to say that plans should be approved at the outset of the project? I'm helping to define our QSR-compliant software development process and wanted to get input. I am pushing for planning documents to be approved at the beginning so as to get buy-in and make these planning documents more meaningful.

Thanks.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Question for you all: the QSR states that "the plans shall be reviewed, updated and approved as the design and development evolves."

Is this to say that plans should be approved at the outset of the project? I'm helping to define our QSR-compliant software development process and wanted to get input. I am pushing for planning documents to be approved at the beginning so as to get buy-in and make these planning documents more meaningful.

Thanks.
Yes, plans should be formally approved prior to their implementation.
 
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