Seeking: Medical Device SOP Templates for several topics

L

LGDeneault

#1
Dear Cove,

I am in search for some "short-but-sweet" medical device manufacturing SOP examples for the following topics:

Technical Files
Supplier Qualifications
Manufacturing Process Control
Indentification and Traceability
Distribution

Can anyone out there help...?

Thanks, in advance, for your time and consideration...

Best of Regards,

LEE
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
LGDeneault said:
Dear Cove,

I am in search for some "short-but-sweet" medical device manufacturing SOP examples for the following topics:

Technical Files
Supplier Qualifications
Manufacturing Process Control
Indentification and Traceability
Distribution

Can anyone out there help...?

Thanks, in advance, for your time and consideration...

Best of Regards,

LEE
Lee:
There is a template for prod ID & Traceability in this post:
http://elsmar.com/Forums/showpost.php?p=80073

This page may help.
http://www.clinivation.com/pages/resources/downloads.htm#policies
 
A

alan smith

#3
Dear Lee

Please be a bit more specific as i may be able to help you. I have worked with FDA standards for several years and i have many templates which may help you.
I'm sure you are aware that FDA standards are quite stringent.

Regards
Alan
 
L

LGDeneault

#5
Many Thanks!

Hi Allan!

I work for a medical device manufacturing company and I am only looking for examples of what is covered (or the high points) in these SOPs. I know that these SOPs are customized for each company but, I can do that for the one that I am working for...

I have written a Quality Manual that points to these specific SOPs and others but, the SOPs on the list that I mentioned are the only ones that are missing in this entire set. If I look at how others have written these SOPs, I can easily modify them to work for my company. Does this help?

Many thanks, in advance, for your time and consideration!

Best Regards,

LEE
alan smith said:
Dear Lee

Please be a bit more specific as i may be able to help you. I have worked with FDA standards for several years and i have many templates which may help you.
I'm sure you are aware that FDA standards are quite stringent.
 
A

alan smith

#7
Seeking: Medical Device SOP Templates

Dear Marc

Please accept my apologies as I have been away on business and unable to access my personal files.

Please find templates for you to use.

Confidentiality is not an issue as the company has been brought out so please do as you please with them.

This is the format layout we used for FDA approvals and I'm sure you are fully aware that FDA have very strict guidelines on document layout and document controls.

I hope these help

If you need further assistance please do not hesitate to contact me

Regards
Alan
 

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