Design Control Procedure

M

Milas

Starting to get Involved
#1
#1
Hi

I work for a medical device manufacturer and been ask to develop a Design Control Procedure. I have very little or no expereince in how to go about writing or developing such a procedure.

Would be grateful if anyone could share such a proceudre or let me know how to go about generating one.

Thank you in advance
 
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E

ECHO

Involved In Discussions
#4
#4
My recommendation is to first write down what your company does at the moment for design control.
Then go through ISO 13485 (especially section 7) and check if every line item is met.
For items that are not currently in line with ISO 13485, add in how you plan on meeting that line item. This forum will be a great to ask specifics.
For items that are in line with ISO 13485, write down which section of our procedure meets the standard. This will be very handy for future audits.
 
J

Junn1992

Quite Involved in Discussions
#5
#5
just work through ISO 13485 or CFR 820 step by step, everything is organized in a logical manner for these 2 standards. I recommend starting from there to get a first draft. After that, do a "experiment" use of the form. You will find some problems/stuff you missed out, items specific to your company process/product etc, then you do a second draft and so on.

Don't expect to get it right the first time, and it dosen't matter if you don't. Because QMS improvements are ongoing throughout the lifetime of the company.
 
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