- We are a UK based device manufacturing company, with a project to expand testing on one of our existing class I products.
This would involve genotyping a number of samples in the UK as well as in the US.
We are looking for a UK based consultant who would be able to pull together the UK data to present to the US for integration of their results. We are looking for a consultant familiar with this sector, also both with UK and US 510k systems.
- We are looking at taking an IVD to the USA.
We would be interesting in talking to members who specialise in FDA topics such as Cybersecurity, Useability and FCC requirements.
If you feel like your organisation could support on either of these projects, please contact Ashleigh who will put you in touch with the relevant contacts