ISO 13485 STORE
Proven and expertly written standards, will save you a minimum of 6 to 9
MONTHS on your implementation
process, easy to use and
simple to tailor to
your specific needs
whether you are
a novice or a
seasoned
professional.
FAST-TRACK ISO 13485 QMS IMPLEMENTATION
Proven and expertly written standards, will save you a minimum of 6 to 9
MONTHS on your implementation
process, easy to use and
simple to tailor to
your specific needs
whether you are
a novice or a
seasoned
professional.
Proven and expertly written standards, will save you a
minimum of 6 to 9 MONTHS on your implementation
process, easy to use and simple to tailor to
your specific needs whether you are
a novice or a seasoned
professional.
Proven and expertly written quality system documents will save you a minimum of 6 to 9 MONTHS on your implementation process, easy to use and simple to tailor to your specific needs whether you are a novice or a seasoned professional.
The Ultimate ISO 13485 Implementation Kit
Say goodbye to costly setbacks and incomplete projects. With our kit, you'll save valuable time, reduce risks, and implement ISO 13485 with confidence. Get 'The Ultimate ISO 13485 Implementation Kit' and get certified on your first try.
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Quality Manual Bundle
ISO 13485 Quality Manual template covering all elements of the medical device industry ISO 13485:2016 standard and applicable regulatory requirements.
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Turnkey Quality Bundle
The Turnkey Quality Bundle includes all standards to fill your gap analysis to ISO 13485 Certification. Additionally, includes consulting services to help train your quality leaders.
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41 page gap analysis checklist covers all requirements of the current FDA QSR, each element of ISO 13485:2016, as well as the supplemental requirements for the FDA QMSR.
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Standard Operating Procedures
Proven and expertly written prcedures will save you a minimum of 6 to 9 MONTHS on your implementation process, easy to use and simple to tailor to your specific needs whether you are a novice or a seasoned professional.
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Gap Analysis
The Turnkey Quality Bundle includes all standards to fill your gap analysis to ISO 13485 Certification. Additionally, includes consulting services to help train your quality leaders.
Learn More ...
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Fast-Track Planning for ISO 13485 QMS Implementation
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Complete Guide on How to Fast-Track your ISO 13485:2016 Implementation
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How to Fast-Track your Plan ISO13485 Certification
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The Fast-Track Approach
Learn From the Fast-Track ISO Expert
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Fast-Track Planning for ISO 13485 QMS Implementation
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Complete Guide on How to Fast-Track your ISO 13485:2016 Implementation
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How to Fast-Track your Plan ISO13485 Certification
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Brian Newbery
Fast-Track QMS Expert & Leader
With over 2 decades experience working as a Medical Device QMS Expert for international companies Brian has the experience, expertise and documentation materials it takes to move Medical Device Companies
from ground zero through to ISO 13485 Certification faster and more efficiently
through The Fast-Track Approach.
With over 2 decades experience working as a Medical Device QMS Expert for international companies Brian has the experience, expertise and documentation materials it takes to move Medical Device Companies from ground zero through to ISO 13485 Certification faster and more efficiently through
The Fast-Track Approach.