Quality tasks for each Design Control Phase

  • Thread starter Tyler Johnson - 2010
  • Start date
T

Tyler Johnson - 2010

#1
I'm fairly new to the design control phases for medical devices from a quality standpoint. Is there a standard view of which quality task should be included in each phase? For example, Phase II should include defining test equipment, risk management activities, define traceability requirements, etc. I know this could be program specific but can someone tell me baseline requirements for each phase for Class III device development.
Thanks
Tyler
 
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Q

Quality96 - 2011

#2
Hi Tyler,

My first question back to you is: What is your position in the company? Is your company ISO 13485 Certified? Basically, your company must have a written Design and Development procedure if the plan is to market a class III device in the US (or anywhere in the western world for that matter). If your company has a QA Manager or Consultant, your best bet is to run your questions by them first. If your company is a "start-up" medical device company that intends on designing a class III device, you will require the services of a experienced regulatory and quality consultant sooner rather than later.

Bill

:2cents:
 
T

Tyler Johnson - 2010

#3
Hi Bill,
To answer your questions, yes we are 13485 certified, I'm a QE and we do have extensive design control procedures in place but I question when some of the quality planning tasks are performed during the different development phases. That is why I'm wondering if there is a generic template that states when certain quality activities take place (which phases contain which quality task). :rolleyes:
Thanks
Tyler
 
Q

Quality96 - 2011

#4
I don't know of a generic template for design controls. My advice would be to develop a template that suits your company's products using your existing design & development procedure. the major topics the template should address are:

Design and Development Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design History File

The template should also layout the formal design reviews to include:
Overall design progress and scheduling,
Review related projects for production and support processes,
Provide feedback to designers on existing or emerging problems,
List of requirements
Action items from previous reviews and/or design meetings meeting
Provide confirmation that the project is ready to move on to the next stage of development.
 
D

DesiQE

#5
Hi Quality96,

My company is sort of a start-up company, making class 2 products. Would you have examples of a design inputs/outputs/V&V to show to my engineers? I have mentioned in other posts that this company's engineers have never worked in a regulated environment and are not exposed to design controls, etc. :frust: So any suggestions/examples would be highly useful and appreciated.

Thanks.
 
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