"QMSR Challenge," Are you ready?
We help you establish your roadmap to QMSR Comliance in 3-steps.
We help you fast-track your ISO 13485:2016 QMS implementation project
and achieve ISO Certification in 4 easy steps.
Fast-Track QMS Consultants
ISO 13485 experts with over 2 decades of experience with medical device quality assurance and regulatory
requirements
Fast-Tracked implementation of quality systems across the globe incluidng ISO 13485 and FDA quality system regulations
Corporate Quality Award winner “Most Improved Site Quality” for medical device manufacturing facility
Are you a medical device company looking to get your
Quality Management System Fast-Tracked?
The Right Solution Could be To Hire an ISO 13485 Expert; Keep Reading to learn more ...
QMS Consultancy
Our consulting services and documentation that we can provide to help you with your ISO 13485:2016 Quality Management System implementation
QMS Consultancy
We can provide consulting services to help with your ISO 13485:2016 Quality Management System implementation.
The consulting can be tailored to meet your needs and can include assisting with the gap, analysis and planning, helping with each step of the implementation, and support with the ISO Certification process
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QMSR Gap Analysis
41 page detailed gap analysis checklist covers all requirements of the current FDA QSR, each element of ISO 13485:2016, as well as the FDA QMSR supplemental requirements.
It can be a great tool to help you identify any gaps in your current quality management system that need to be filled in order to be compliant with the QMSR.
Implementation Planning
After the Gap Analysis is complete the next step is to develop the implementation plan for your medical device QMS.
Our download Planning Kit designed by ISO 13485 experts, provides guidance on developing the implementation plan for your medical device manufacturing QMS. The plan will include all steps up to and including iso certification
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Implementation Projects
Includes QMS consultancy help with the implementation by providing through our website store, templates for SOP’s and quality manual.
We then help to customize the documents to suit your medical device. Also provide QMS training for your employees, conduct audits and help with any corrective actions. This fast-track approach can save 6-9 months overall
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Certification Support
We can partner with you to provide coaching and support for the ISO Certification process.
Including advice on the selection of a recognized certification body, training of your employees on what to expect & how to behave during the certification audits. Certification is a multi-step process so planning is important & we can advise and assist with this final step.
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Internal Audits
Our Lead Auditors can conduct internal audits during the implementation process and as SOP’s are implemented.
Also provide training and coaching for your own internal audit team as required. Assist with identifying improvement opportunities and corrective actions and to help prepare for the ISO certification audits.
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Foundation Training
Conduct training for your management and employees on Introduction to ISO 13485 quality management systems and medical device industry regulatory requirements.
Also training on individual SOP’s as required, i.e. risk management, CAPA, complaint handling, management review, root cause analysis, design controls, process validation etc.
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Internal Auditor Training
We can provide internal auditor coaching during any internal audits we conduct of your QMS, or we can provide through our consulting partners, Certified Internal Auditor training.
If you use our SOP for Internal Auditing this would include training for this procedure.
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Lead Auditor Training
We can set you up with Accredited Certification Lead Auditor Training through our consulting partners.
We can further support your lead auditor training during any internal audits we assist with during your ISO 13485 quality management system implementation.
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Brian Newbery
ISO 13485 QMS Expert and Founder of Fast-Track QMS Consultants
With over 2 decades experience working as a medical device QMS leader for international companies I have the experience, expertise and documentation materials it takes to move start-up companies from ground zero through to ISO 13485 Certification much faster and more efficiently than they could likely do by themselves.
It has been a mission of over two decades that I have learned the best practices in designing and completing the documentation materials, training packages to fine tune the fast-track approach.
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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 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 who is both practical and has the experience and knowledge to help fast track your implementation of the
ISO 13485 Quality Management System.
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Learn from from years of experence and deep expertise the best practices to fast-track your ISO 13485 Quality Management System Implementation.