CASE STUDY Compliance to IEC62304 achieved within 4 weeks [Sassy_Social_Share] CASE STUDY Compliance to IEC62304 achieved within 4 weeks [Sassy_Social_Share] Full IEC62304 compliance through tailored 4 week action plan The start-up venture required support to help document and reach compliance to IEC62304 within a tight timeline ready for their medical device audit. Outcome IEC62304 Checklist:…
CASE STUDY Securing FDA and CE Marking approval for HoloCare AS’s Class IIb medical device [Sassy_Social_Share] CASE STUDY Securing FDA and CE Marking approval for HoloCare AS’s Class IIb medical device [Sassy_Social_Share] Delivered compliant technical file documentation to achieve market approvals Healthcare startup, specialising in augmented reality application for surgical planning. Outcome Integrated seamlessly: With…
CASE STUDY Sensory feedback insole delivered for NHS CEP. CASE STUDY Sensory feedback insole delivered for NHS CEP.Proof of concept delivered to gain future funding for development Nicki partnered with us to develop a smart insole that would improve walking and posture of people with autism. Outcome Rapid prototyping: Designed and developed a functional insole…
CASE STUDY Multi-sensor chest wearable prototype developed to enable data collection for healthcare startup tackling remote patient access to healthcare. CASE STUDY Multi-sensor chest wearable prototype developed to enable data collection for healthcare startup tackling remote patient access to healthcare.Prototype to enable data collection for remote patient monitoring FutureCare partnered with us to develop a…
CASE STUDY Prototype achieved within just 2 weeks for healthcare startup tackling smart wearables for the elderly [Sassy_Social_Share] CASE STUDY Prototype achieved within just 2 weeks for healthcare startup tackling smart wearables for the elderly [Sassy_Social_Share] Prototype rapidly developed in just 2 weeks Healthcare startup, specialising in a movement sensing insole for the elderly, partnered…
CASE STUDY Life-saving remote blood cell counting prototype delivered 3 months before deadline [Sassy_Social_Share] CASE STUDY Life-saving remote blood cell counting prototype delivered 3 months before deadline [Sassy_Social_Share] Prototype achieved 3 months before deadline Partnering with us, this healthcare company reduced their development time by 3 months in time for clinical trials OUTCOME Consolidated documentation:…
CASE STUDY Start-up venture achieves Class I CE status just 6 months from prototype [Sassy_Social_Share] CASE STUDY Start-up venture achieves Class I CE status just 6 months from prototype [Sassy_Social_Share] In 6 months Class I CE status achieved The start-up venture partnered with us to achieve Class I CE Status just 6 months after prototype…