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
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.
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
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.
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.
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.