QMS Guru

QMS Gury offers affordable answers for your company related to medical device or biotech therapy questions. We will give tailored solutions on those. With over 25 years of experience we know everything about quality management systems, qualification, validation for processes or products, medical device regulations and much, much more. With our solutions will meet your commercial need, being affordable and fitting your organization. In our unique way we help you to become the expert.

How it started

QMS Guru was founded on April 11th, 2019 with the mission to serve patients better.

Although founded on that date, the idea took final shape in the Summer of 2018. However, the initial idea started actually many years before 2018. When working in QA, he experienced firsthand the benefits of applying basic quality principles in large multinationals, and the lack of resources or knowledge in smaller local organizations. Customizing resources and needs would have solved the problem for the smaller organizations. However, at that time there did not seem to be a market for such a service.

Recently, acting as QA manager at InSciTe, he discovered that there was market after all. When receiving the appreciation from all the projects and clients he supported, he was convinced that there was a need and a viable market for such service. That was in the beginning of 2018. During that time, he also found out that the shared services, shared resources and shared knowledge of InSciTe were only available to a small group. During his Summer holiday of that year, he thought, how can more people benefit? That was the time the idea behind QMS Guru slowly began to take shape. It was only in the beginning of 2019 that he decided to do this on his own and in his own QMS Guru way.

If you want to discover what QMS Guru can do for you, please do not hesitate to contact us. Discover us.

QMS Guru
Raymond Mulleneers

Company’s Keywords:

medical device regulaitions, qms creation & certification, oq, cleanroom development & validation, iso 134852016, technical file creation, project manager, iq, pragmatic problem solver, certified lead auditor, pq, all standards related to iso 134852016, iso 141552011