Netherlands
Enthusiastic, analytical and empathetic quality, regulatory and data privacy specialist from the UK with hands-on experience of the regulatory approval process in the EU for innovative AI/ML-based medical device software, and of creating a quality management system from scratch at medtech startups, most recently at Healthplus.ai in Amsterdam. With a keen interest in social justice, the environment, health and wellbeing, and lately the opportunities and social and ethical challenges of AI technologies. I have a social science background with a first class degree in Human Geography, for which I conducted participatory research as a volunteer for a community health intervention related to HIV/AIDS prevention in Togo, West Africa and I regularly volunteer in the community to support marginalised people. Taking some time out to reflect and recalibrate before looking for an exciting new opportunity in the medtech field!
Hands-on role with broad scope of responsibilities at this early stage startup. Involved in all aspects of preparing an AI/ML-driven medical device software (a clinical decision-support tool that estimates the probability of a patient developing a bacterial infection after surgery) for regulatory approval in the EU, from the concept phase to submission of technical documentation to the Notified Body. Key accomplishments: - Kicked-off certification process, defined regulatory strategy and contracted Notified Body - Drafted and implemented quality procedures making up the Quality Management System, compliant with ISO 13485, alongside QA/RA Manager - Worked closely with technical team to ensure that product development complied with regulatory requirements from MDR and from relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366-1) - Input into Clinical Evaluation Plan according to MDR, MEDDEV and MDCG 2020-13 - Input into Risk Management: preliminary product risk assessment - Usability: Liaised with design agency to conduct formative user research with clinicians, formalised final user needs (for 1st product release and for roadmap) and developed technical and non-technical product requirements, risk assessment of user interface - Drafted Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up plans - Data privacy compliance: identification of key requirements from GDPR for Healthplus.ai and drafting of company procedures and policies to fulfil these (data breach procedure, information security policy); drafting and amendment of data processing agreements - Researching best practices for development of AI/ML prediction models for use in clinical practice and translating these into documentation requirements for the team - Human resources: recruitment and onboarding of Lead Data Scientist, UX Researcher and QA/RA Manager; drafting of Human Resources and Skill Management processes, including PDP process; Employee Manual
Worked in a close-knit team to document the product development and implementation process for decision-support software which applies machine learning techniques to health data, for application in the medical and healthcare field. - Prepared a product technical file on Pacmed's first software product, developed for Dutch ICUs in close collaboration with Amsterdam's VUmc, submitted for CE certification according to the EU's Medical Device Directive, ISO 13485 standard and other related standards. - Development and roll-out of the Quality Management System, including writing and review of Standard Operating Procedures related to the software development process and all supporting processes - Participation in on-site audits conducted by Notified Body and follow-up on nonconformities generated during the audits, following the Corrective Action Preventive Action (CAPA) process - Support with planning of internal audits and preparation of audit reports - Support with planning of periodic training of QMS processes - Document and record control