We partnered with a MedTech Digital Solution provider to design and develop their digital solution and to gain acceptance onto a national procurement framework within the NHS.
Whilst working with their team we assured their design and test processes to ensure that Clinical Safety rigour had been incorporated into the product. Together we achieved compliance to DCB 0129 and CATR for their product. Significantly, we also passed a rigorous NHS Digital procurement assessment process resulting in a product listing on the national NHS buyers catalogue.
Using our specialist advice and experience we rapidly established business wide processes and a governance framework achieving ISO27001certification and a framework listing at the first pass. Through this process the company also achieved DSPT and Cyber Essentials Plus certification.
As Director and CFO of a healthtech company that has undergone significant change over the last 12 months with staff changes and new product development. Our governance and compliance work had faltered during this period and we needed urgent help to get us back on track and help facilitate sales into the NHS.
We chose Framework Genie because they quickly understood our issues and tailored a service package to effectively pick up the reins and work with my team to complete our ISO 9001/27001 re-certification, Clinical Risk Management, DSPT and prepare us for NHS DTAC.
Framework Genie proved to be really effective, not only did they get us back on track, their planning and organising together with their ways of working added significant value to the business mentoring my team. Their approach simplified what was initially daunting to us and made it much more straightforward and ultimately successful. Director