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ISO 13485 document template:

SOP-739-01 
Control of Design and Development Changes
 

This procedure along with the ECR form describes the process and requirements for controlling and approving minor design changes. Includes the process for identification and documentation of the changes, review and approval and validation of the changes as appropriate. 

 

 The document is fully editable that you can customize to suite your prduct and companies QMS.
 

 Blue font areas indicate where some customization may be required.
 

Each SOP purchase includes unlimited email support for any assistance you may need.


US $149

THIS TEMPLATE IS

ALSO AVAILABLE AS

PART OF OUR

TURNKEY BUNDLE

OVERVIEW

Price
US$ 149.00
 

Compliant with
ISO 13485 clause 7.3.9
 

Format
Microsoft Word All Versions compatible
 

Number of pages
5
 

Document language
English


Content
Includes ISO 13485 as well as Best Practice recommendations

USABILITY

Can I edit the document?
Yes. The document is fully editable – just enter information specific to your company.
 

Can I use this to become certified?
Yes. The documentation template may be used for ISO 13485 certification audit purposes.
 

Compatible for all companies
Formated for start-up companies to mature companies
 

 

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DOCUMENT FEATURES

F.A.Q

 BUYING INDIVIDUAL ISO 13485 DOCUMENT TEMPLATES

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You may pay with major credit card, or via wire transfer from your bank account.