Design Control Assistance required

W

Woodray

Hi,

I have a new start up and I have decided to put the QMS in order first before engaging in any activities for the company. My first stop is Design and Development - Chapter 7.

While I have managed resources for the Quality manual and some SOP's for Design Control, I cant find some standard templates that I can use to modify them to what I need.

I intend to develop Class III medical Device and require help with getting formats of the following SOP's

SOP 7 – 001 Design and Development Planning
SOP 7 – 002 Design Input
SOP 7 – 003 Design Output
SOP 7 – 004 Design Review

Would appreciate any assistance. If you don't want to post it her, you can send a a message to me.I will only use it as a reference and as all of you know, it needs to be customized to my needs, so still need to do work but makes life a little easier

Thanks

Ray
 

sagai

Quite Involved in Discussions
Hi Ray,
It sounds strange that for a class III device manufacturer there is nothing for design control in the qms. Is there noone to provide it for you?
These design control processes are tailored to your company, so quit frankly I do not know how far can you go with a canned process template. There are some on the internet if you google it however.
Further, target markets for now and the plans for the nearby future also determines the extent of your work for these SOPs, that surely will not be in any template.
Hope these may help.
Cheers
 
W

Woodray

Hi Sagai,

Thanks for your reply.

I am a one man start up company that is going to develop a class III device. My first step to develop a QMS. So I am starting from scratch and developing a QMS. You are right that each manual/SOP has to be customized to the company's requirements. So what I have done so far is to take what is available and modify it sometimes adding more than 50% content to cater to my requirements.

So yes it is helpful to get a SOP out there and then it have it customized to what you need.

As my first task is to develop and design a device, I am focusing on this section and as I develop and design, I will improve on the SOP etc

If you have a sample, I would appreciate it very much

Thanks

Cheers

Ray
 

sagai

Quite Involved in Discussions
I have randomly checked a few sites, here are the ones I have come across with:
https://alvintai.com/wp-content/uploads/2015/01/Design-Control-SOP.docx
http://philt.com/uploads/3/2/3/8/3238504/finaldraft_sop-003_design_control.pdf
http://sayasystems.com/htmlResumeMPZ/CORP.820.30.sopV1.4.c1.pdf

One more thing maybe, that if you are building it from scratch, I would think of to drop the idea of having “a” tangible document for SOPs.
There are knowledge management tools do that in a more manageble manner.

Cheers
 
W

Woodray

Thank you for the inputs. The difficulties I have is in SOP at the lower level of Design Input, Output; Product Development and Design Planning etc. If you have any SOPs specific to these would be helpful
 

Mark Meer

Trusted Information Resource
I have a new start up and I have decided to put the QMS in order first before engaging in any activities for the company...

:agree1:

I intend to develop Class III medical Device and require help with getting formats of the following SOP's

SOP 7 – 001 Design and Development Planning
SOP 7 – 002 Design Input
SOP 7 – 003 Design Output
SOP 7 – 004 Design Review

As sagai has already stated, SOPs are tailored to your own needs, so it's difficult to advise generically.

But, for what it's worth, the only suggestion I might submit is that you consider NOT having such granular SOPs. Instead, consider just a single SOP that covers design and development in general. Some of the reasons are as follows:

1. Simplifies documentation control - less documents.

2. These elements are all inter-related. If you were to create a process flowchart for D&D, it would include all these elements...so why isolate them procedurally?

3. (related to the above) Chances are that anyone involved in D&D are going to need to know all these elements, and the way they interrelate. So, for training purposes, why not present it all together?
 
W

Woodray

Hi Mark and Sagai

Ordinarily I would agree with you in keeping SOP's etc simple but in this case the SOP is not merely to get certification but will become my template to design and develop the product. In essence, it will start with a standard template modified to suit me as I see it now but it will evolve as I move on to different stages of the design and development of my class 3 device.

One of the key elements is getting into a development partnership with an R&D based company whereby they can bring in to reality the concept and inputs I develop through my analysis and research of the existing market and the gap analysis of the ideal requirements of the market and hope to get closer to the concept of an ideal product.

So, if you have a template, I would be very grateful for your help. Thank you
 
Top Bottom