Gerard Kool

Background

About Gerard Kool

Co-Founder / Operations Director @ aos-hub.com /@sparca.com - 2017-Present Leadership of operations across technology group focused on medical device software for the Optical industry (retail and clinical) and image processing solutions in the mobile and web sectors, collectively growing from 3 founders to 30 employees with international presence. Director and board member. Strategic Business Development Managed through to exit via structured buyout (AOS) Contributed to securing approximately £10M in funding Managed strategic partnerships with OEMs and major retailers, Qualcomm, Vision Express Directed R&D delivery across diverse sectors - biometrics, consumer electronics, civil eng. Road mapping, strategic business proposals, forecasts, new revenue stream development Operational Excellence Established development, IT infrastructure, service and information security functions Implemented comprehensive change management systems to meet ISO requirements Created project tracking and issue management workflows using Atlassian suite Created HR, onboarding and training programs aligned with ISO13485 & ISO27001 Technical recruitment, building effective development and compliance teams (UK & offshore) Regulatory & Quality Leadership Person Responsible for Regulatory Control (PRRC) for EU MDR, FDA and MHRA Experience with TGA (Aus), CDSCO (India) Developed & authored policies for QMS / ISMS for ISO 13485 / 27001, accredited since 2018 Authored policies for documentation-first approach Ensured continuous compliance with medical device regulations for Class IIa SaMD products Technical & Product Development Led transformation from desktop software to SaaS platform to SDK & API-first model Directed development of Visual Acuity, trialled by Alcon (US) & Vision Express (UK) Research projects at Universities including Anglia Ruskin (UK), University of Salento (It)