What do we do and what is this website for?

It all began with getting a proton therapy centre approved…

What we have been good at all along: Develop medical devices ready for approval – and also support during the approval process. And this is why we were approached, whether we could support during the approval process of the first commercially used proton therapy centre, approval which was both extremely sophisticated and politicised. This was our very first consulting project. It was directly followed by helping to establish a QM system for and gaining certification of a new business unit of SIEMENS (back then) Medical Solutions in Erlangen and Munich. Upon these two side trips to a world that had been strange to us up to then, we received more and more requests for consulting services. As the demand didn’t even decline when the hype about migrating all active medical devices from 2nd to 3rd Edition of the IEC 60601-1 was over, we decided in 2013 to establish a third business unit "Consulting, Quality Management and Regulatory Affairs" in addition to the two units Development and Production.

Since then we support our customers in the range of all topics and tasks displayed on this website by the aid of a constantly growing, multidisciplinary team. We are delighted by experienced fellows at all times (if you are interested click here) that similar to us take pleasure in constantly tackling new challenges and leaving behind satisfied customers at the end of a project, being able to help with solving their tasks.

REGULATORY AFFAIRS – NO RISK MORE FUN

We have brought this website into being to inform you constantly and ever current about the most important topics that are relevant to all regulatory fields within medical technology. On this site you receive information on new trends, legal and regulatory requirements at an early stage as well as insight into our projects keeping us busy every day.

It is our aim to inform you in good time to provide for "MORE FUN THAN RISK". Because we all devoting ourselves to those topics every day know that it can be fun as well.

 

seleon-consulting competence spectrum

Regulatory Affairs

Gaining approval for medical devices is complex and quite often also confusing. We bring clarity…

> Regulatory Affairs

Clinical Approval

Clinical approval of medical devices requires numerous evidences and evaluations. What we know about it …

> Clinical Approval

Quality Management

Medical devices are governed by stringent requirements on quality assurance. We know the details …

> Quality Management

Development Excellence

Product development of medical devices is subject to its own rules. We bring light into the darkness …

> Development Excellence