Procedure for Completing Medical Device Project Plans

A

Apple Bob

#1
Hi there I am a quality engineer working in medical devices; I have been tasked with generating a procedure for completing Project Plans. Rather than reinvent the wheel I thought that I would check to see whether anyone has got a rpocedure that can be modified to suit my requirements.:)
 
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B

brahmaiah

#2
Hi there I am a quality engineer working in medical devices; I have been tasked with generating a procedure for completing Project Plans. Rather than reinvent the wheel I thought that I would check to see whether anyone has got a rpocedure that can be modified to suit my requirements.:)
You may adopt the TS3 APQP model to plan any project.
V.J.Brahmaiah
 

Ajit Basrur

Staff member
Admin
#3
Hi there I am a quality engineer working in medical devices; I have been tasked with generating a procedure for completing Project Plans. Rather than reinvent the wheel I thought that I would check to see whether anyone has got a rpocedure that can be modified to suit my requirements.:)
Welcome to the Cove :bigwave:

Any responses pl ?
 
M

MIREGMGR

#4
I don't understand the question. This is going to be a procedure for implementing a plan? Isn't a plan a procedure for accomplishing a task?
 

Marcelo

Inactive Registered Visitor
#5
I think he´s in need of explanation of what a plan might contain, hance the "procedure to develop a plan". I´m doing this for a cliente now, because they are not used to planning, so i´m develoing a template plan (sorry, not completed yet and just in portuguese).

It really depends on the device and company.
 
L

Laura Halper

#6
Hi Apple Bob,

The FDA and ISO both have some basic requirements for content of a design and development Plan. So at a minimum, be sure your Plan addresses these if your device is sold in U.S. or in a country that requires ISO 13485.

21CFR 820.30(b) requires the plan to "describe or reference the design and development activities and define responsiblity for implementation. The plans shall identify and describe the interfaces with different groups or activites that provide, or result in, input to the design and development process."

ISO 13485:2003 states that "During the design and development planning, the organization shall determine a) the design and development stages, b) the review, verification, validation and design transfer activites that are appropriate at each design adn development stage, and c) the responsiblities and authorities for design and development"

ISO/TR 14969:2004 (Guidance on the application of ISO 13485:2003) has a more detailed discussion of what elements are typically addressed in the design and development plan. The discussion is too lengthly to include here, and the standard is copyrighted, so I can't attach it. But it might be worthwhile purchasing a copy.

Regards,
Laura

P.S. Do your friends just call you "Apple"?
 
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