Turnkey Quality Bundle Includes:
ISO 13485 Quality Manual template
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.
36 Form templates that support the QMS SOP’s
Email support for review of your documentation before release
1-hours of free online consultation to support the customization of the documents in this package.
Turnkey Quality Bundle Includes:
ISO 13485 Quality Manual template
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.
36 Form templates that support the QMS SOP’s
Email support for review of your documentation before release
1-hours of free online consultation to support the customization of the documents in this package.
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© 2023 Fast-Track QMS Consultants. All rights reserved.
© 2023 Fast-Track QMS Consultants. All rights reserved.
26, Lane Street New York, USA
9AM - 7PM Mon - Sat
info@company.net +55 11 3256.9856
26, Lane Street New York, USA
9AM - 7PM Mon - Sat
info@company.net +55 11 3256.9856