Turnkey Quality System Bundle
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Turnkey Quality Bundle Includes:
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ISO 13485 Quality Manual template
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41 - ISO 13485 QMS Procedure templates covering all elements of the ISO 13485:2106 standard, FDA requirements and applicable regulatory requirements.
The SOP Templates are written in MS Word for easy customization as required to suit your company’s medical devices. Blue font is used to indicate where changes may be required to suit your QMS and product, however the vast majority of content will cover your ISO 13485 QMS requirements.
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36 Form templates that support the QMS SOP’s
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Email support for review of your documentation before release
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1-hours of free online consultation to support the customization of the documents in this package.
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Price $1,897.00
Boonsit Chungsirporn
Executive Director TPI Glove Division
When I need help from an experienced quality system professional to act as a consultant for a start-up medical device company, I’m extremely fortunate and happy that I know Brian Newbery through our working together for 12 years when we both worked for a major multinational major medical device manufacturer.
His experience and knowledge of the ISO 13485:2016 quality standard and USA FDA regulations as well as many other international regulations continues to be a major source I go to on a regular basis.
I can highly recommend Brian to anyone looking for a quality system consultant that is both practical and has the experience and knowledge to help fast track your implementation of the
ISO 13485 Quality Management System.