If you seek quality guidance

Our solutions for your medical devices and biotech therapies questions are unique and tailored, to meet your need. Addressing Tech. file, QMS, qualification, validation, regulatory questions and more. Discover what we can do for you.

Together we will serve patients better and faster

~ Raymond Mulleneers, Founder QMS Guru
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  • Diverse and broad QMS knowledge

    25 Years of experience in quality roles in different disciplines of industry from printers to space applications, in the automotive and medical devices industry. This all contributed to the diverse person the founder became. It strengthened his ability to solve, create and  implement the most difficult challenges. He is known for making the impossible possible, a real QMS Guru.

  • Master in development solutions and projects

    QMS Guru follows the philosophy that nothing is impossible and that there is a solution for everything. If you combine this with a strong drive, vast knowledge and experience, it is obvious that together we can master every project.

  • QMS Guru creates a learing environment

    It is not in the QMS Guru philosophy to do the things for you. On the contrary, we teach you how to succeed.

  • Deliver tailored service to your business

    We all know that spending time is easy, but knowing how to spend it wisely can be a real challenge. Francis Bacon (scientist, 1561-1626) said that history make men wise. That is where QMS Guru can help. We tailor your needs to ensure you do not spend your future but invest in your future. Our tailored services will reduce your time to marked significantly.

Services

Quality system creation

QMS guru owns a complete library of all types of documents required for Quality, a process or a device. Whatever you need we have.

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Quality systemtraining 

We link your processes to the applicable parts of the standards and we teach you why and how this can benefit you. 

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Qualification, 
Validation

Qualification and validation is about proof that your processes are under control. How to do that? QMS Guru will teach out how. 

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Tech file creation

What and how should you create your technical file for submission? QMS Guru will teach you.


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MDR training

We will direct you in implementing the Medical Device Directive (MDR), learning you how to read it in relation to your organization.

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General support 

Do you know how to get from "A" to "B"? 
QMS Guru can guide and support you to achieve your goals.

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QMS Guru history roots

History make men wise. 
~ Francis Bacon (scientist, 1561-1626).