Since October 2022, BEO BERLIN has been offering a customised service package for start-ups in the medical technology field.
The goal is to set appropriate priorities for the implementation of regulatory requirements that are relevant for the respective company. The package includes workshop elements, customised templates, assistance with the preparation and space for your questions. BEO BERLIN works with you to develop customised solutions. Meet the BEO BERLIN team at the MEDICA trade fair and get the conversation started.
BEO BERLIN and start-ups have been working together for a long time on various projects, especially in orthopaedics and rehabilitation technology. Founder and Managing Director Michael Vent draws conclusions from practical experience:
In our experience, it is very difficult, especially for newcomers in the medical technology field, to assess which hurdles need to be overcome and when. In our opinion, basic seminars, such as those offered in large numbers, are too generalised. As the inventor of a new mobility aid, why should I have to deal with the requirements for X-ray devices? This is often a waste of time and also very daunting.
Having read and understood the MDR is not quite sufficient. Many things look different in practice than in the regulation. Financial means and time resources must be used precisely to avoid duplicate testing, to avoid wasting time, to avoid dead ends, to avoid regulatory difficulties. Which certified or non-certified components can or should I use? Which standards must or can I use? Which certification partners should I consult and when? Which approval documents should I invest time in and which should I postpone? What does it cost me to be regulatory untouchable? And in general, what alternatives do I have at each stage of my journey?
There are countless other individual questions. BEO BERLIN wants to help start-ups gain more security and a better feel for the "conformity assessment procedure according to MDR" project. The company wants to minimise the risk of being held up or even stopped by stumbling blocks.
Why a package and not an à la carte approach? The latter is applicable if regulatory experience with medical devices already exists and specific tasks need to be completed.
The package in return offers budget security, as it has a fixed price and allows you to set priorities without being off the mark. It is therefore not a black box with unknown content, but an aid to selecting what is appropriate and relevant for your company from BEO BERLIN's large toolbox.
