Quality Management System Training and Consulting
Welcome to just QMS. We are Quality Management System consultants, offering QMS training and simple QMS solutions for medical device, pharmaceutical and life science companies.
What’s New
QMSR Final Rule Training
Just a few weeks left to implement the FDA Quality Management System Regulation (QMSR) final rule. This regulation applies to medical device companies in the U.S., and will replace the current 21 CFR part 820 on February 2, 2026. It’s time for your implementation team to train.
Our Services
Explore a wide range of services tailored to your needs.
GMP and QMS Training
We offer a variety of training courses on QMS and GMP topics. Check out the online training and in-person training options.
Consulting
Do you need to implement a new quality management system, or changes to your QMS to comply with a new regulation like QMSR? Do you want to implement an eQMS solution? Our experienced team can do it for you.
Documents
Simple, compliant documents that work are our specialty. We’ve seen it all, and we can provide you SOPs, forms and templates that are right for your business.
Testimonials
Hear what our satisfied clients have to say about their experiences with us.
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Kathleen helped Darroch Medical plan, develop, and deploy its QMS in an extremely timely and efficient manner. From a small business perspective, she was able to give us guidance on industry standard practices and customize documentation to fit our needs. 5/5!
– Anthony Shao, CEO and President, Darroch Medical Solutions
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I have worked with Michael for over a decade on multiple medical device projects…from CAPA investigations to process changes to implementation of IVDR regulations. I find Michael knowledgeable on how to interpret and implement quality systems and a real asset on how to work efficiently in a cGMP environment.
– Carl Hulle, Director of Process Engineering, QuidelOrtho
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Michael implemented a new electronic QMS system (MasterControl) to comply with ISO 9001:2015 for our startup site. His performance, knowledge, ability to execute on time, and to dig in and make things work was spot on and helped us achieve ISO 9001 certification in a 9 month period.
He’s extremely knowledgeable regarding quality standards and medical devices regulations, and can apply this knowledge readily to ensure compliance with current requirements. I would not hesitate to hire Michael again to set up another QMS, or to perform training services – his knowledge is very in depth, and he is a gifted communicator and teacher.
– Rachel Liechti, Quality Manager, ThermoFisher Scientific
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Kathleen assisted our small business in the implementation and maintenance of our QMS. Her experience and solution focused approach has enabled alignment and compliance of our system with ISO 13485. Her continued support, feedback, and proactive approach have been invaluable for us in the identification and application of improvement for internal processes and documentation.
– Sari Luciano, CEO and President, Vault Paragon Group