Regulatory
Affairs

For constructing a theory, sufficient experience is needed.

At the very start there is a vision, an idea or maybe even a detailed specification initially sparking a more complex project than expected. Most of the time the beginning of the product life cycle until market access is difficult to judge for many companies without experience. In case of medical devices or medical software the cost and time wasters are often located in different spots, but appropriate experience allows for clearly allocating them beforehand.

Predictable. A simple word – but who owns a crystal ball for looking ahead.

The complexity of a development project can be linked to planned project duration, the required development resources, the designated iterations or the amount and quality of necessary suppliers, and be foreseen for the same. Provided one has gained adequate experience from all kinds of projects and knows every trick in the book. In any case it allows you to plan with certainty and to establish budgets and project plans that remain approximately equal between planning and project start. That's half the battle.

 

Realisable. With the right team and the right momentum.

Your success and a clean sweep possibly made to gain series stage depends on good planning and preparation. Steer clear of development rocks and time-consuming approval narrows by conducting project audits at early stages. Consideration of potential project risks is ensured by partners boasting know-how from numerous projects: knowing the approval criteria already during the development phase of a project allows for a smooth approval procedure and all the calmness needed on your way to production.

 

Calculable. With seleon from development throughout approval to production.

seleon gmbh has been developing and producing complex equipment for customers in the medical technology field since 1998, growing into a leading medical technology service provider. We develop individual solutions in partnership with our customers around the world, quickly leading to success. With our team of experienced physicists, engineers, computer scientists, process engineers and consultants, every one of our projects reaffirms our ambition to find innovative solutions and help our customers succeed in the market.

 

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