BEO BERLIN and start-ups have been working together for a long time on various projects, especially in orthopaedics and rehabilitation technology. In our experience, it is very difficult, especially for new heads in medical technology, to assess which hurdles need to be overcome and when. In our opinion, the large number of basic seminars offered 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 off-putting.
Questions that we receive during this phase include:
- Which of my components should already be certified or can I work without them?
- Which standards must or can I use?
- When and where do I have to do a clinical trial, or do I need to do one at all?
- What should and what must I write in my instructions for use?
- Which certification partners should I consult and when, or is there an alternative?
- In which authorisation documents should I invest time during which project phase and who will help me?
- What does it cost me to be regulatory inviolable?
- And in general, what alternatives do I have at every point along the way?
Es gibt unzählige weitere ganz individuelle Fragen. Wir möchten helfen mehr Sicherheit, mehr Gefühl für das Projekt „Konformitätsbewertungsverfahren nach MDRproject. We want to minimise the risk of being held up or even blocked by stumbling blocks. Why a package and not an à la carte approach? The latter is applicable if you already have regulatory experience with medical devices and there are specific tasks to be completed. The package, on the other hand, offers budget security as it has a fixed price and allows you to set priorities without going wrong. It is therefore not a black box with unknown content, but an aid to select what is appropriate and relevant for your company from BEO BERLIN's large modular system.
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