Through my consulting business, I help medical device and health app manufacturers with all aspects related to developing software in the medical devices industry. Additionally, I offer my expertise as a software specialist to notified bodies as an auditor or product reviewer.

* In this position, my main responsibilities are to: * Meet with clients to understand, analyse and challenge the business needs. * Take part in new product development, perform functional analysis and design solutions. * Analyse and describe the operation of existing systems. * Define business (functional) and operational (non-functional) requirements, and translate them into system requirements. * Communicate with software developers to find the most efficient and cost-effective solutions. * Perform functional risk analysis on information security and patient safety where applicable. * Support QA to define the testing strategy, scenarios and acceptance criteria. * Present the functional system requirements to stakeholders. * Ensure operation by training client personnel and providing documentation and support. * Perform and document "design control" and "risk management" in order to ensure systems compliance with applicable health regulation and standards.

During this period at Minze, I developed the Minze Clinician Portal (web application in JavaScript/AngularJS) for urologists and physiotherapists. I was also responsible for managing the development of our mobile application for patients (React Native), our backend application (Java Spring), and our cloud architecture (Google Cloud/AWS).

* My main responsibilities in this position are: * Defining software requirements and performing QA. * Regulatory compliance, defining software development procedures conform to ISO 13485, IEC 62304, and GDPR, and participating in audits. * Designing, improving and maintaining various parts of our technology stack, including a web application, mobile applications for both iOS and Android, a backend application and number of microservices. * Cloud engineering and DevOps on AWS.