Quality Manual Bundle
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ISO 13485 Quality Manual template covering all elements of the medical device industry ISO 13485:2016 standard and applicable regulatory requirements.
Uses 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.
The Quality Manual Bundle includes the manual template along with:
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A Cross Reference Addendum template which references the applicable procedures which are available as part of the Turnkey Quality System Bundle
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A Quality Plan template which can be used for the company’s annual quality planning and quality objectives
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Guidance Document to help you customize your ISO 13485 Quality Manual
Digital Product
Price $499.00
Turnkey Quality System Bundle
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Quality Manual Bundle
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50 Procedures (SOP’s) covering all elements of the ISO 13485:2016 Standard. Similar to the Quality Manual the SOP’s are written using MS Word and blue font in those areas that may require customization to suit your company. These SOP’s also cover the requirements of the FDA 21 CFR 820 Regulations.
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43 Forms and templates that support the SOP’s
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Free updates to included documents as well as any additional documents as they become available.
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Training materials for some of the key procedures required to kick off the fast-track implementation.
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10-hours of free online consultation to support the customization of the documents in this package.
Digital Product
Price $5,895.00
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.
Implementation Products and Consultation
Free Fast Track ISO 13485 Implementation Kit
Our free fast track implementation kit is for businesses that have not started the planning or implementation of their quality management system.
Free ISO 13485 Gap Analysis
Our Free ISO 13485 Gap Analysis is for organizations that may have already started the development and implementation of their manufacturing capability and their quality management system.
Consulting Services
Focus in on the areas of your quality management system that need the help to complete your implementation and achieve certification.
ISO Implementation Product Bundles
Successful ISO 13485 implementation and certification.
