We are a medical-technology company based in London UK, specialised in software and we work in the ophthalmology (medicine of the eye) arena.
Our software solutions are very simple, we take images which have been externally captured by other hardware products (e.g. a medical cameras), and we enhance some of the features within the image.
Our software solutions are not used for surgical or critical medical operations, but as already mentioned only to enhance and extract some of the features within the images. Hence, it can be useful to use this software for Follow-Ups and for general monitoring and assisting diagnosing.
The software now needs to reach its commercial level and therefore requires certifications (e.g. CE marking, etc.) and all the required regulatory processes. Therefore, we are looking for an initial consultation which might lead to more work (managing all the certification processes to commercialise the software).
In this initial consultation we would like to discuss with the most suitable candidate:
1) All the steps required to certify such medical software in order to reach commercialisation
2) Make a detailed management plan
3) Determine all the costs (e.g. regulatory engineer, notified body, etc.)
4) Determine a timeline for the project
We are looking for an experienced (>15 years) person which can also provide proof of their previous work.