As a Senior Software Architect and CTO, I combine technical leadership with project management, specializing in medical devices conformity and AI integration for change management. I hold AWS Certified Cloud Practitioner and Certified TensorFlow Developer credentials.During my 7-year tenure as co-founder and CTO of GenomSys, I secured 14M CHF in funding, led the development of the ISO/IEC 23092 standard for genomic information, and achieved CE marking and EU MDD certification for diagnostic software products. I ensure quality and compliance in medical software development, focusing on IEC 62304 standards, software verification, and validation.I have extensive experience with ISO 13485 conformity and managing electronic Quality Management Systems (eQMS) for medical device manufacturers. I perform comprehensive medical device documentation gap analysis against standards and guidelines, ensuring compliance and efficiency.I have integrated AI and LLM into internal company operations for efficiency and change management, using tools like CustomGPT and AI agents to optimize workflows and improve decision-making.I have filed 12 patent families, resulting in over 80 patents granted.Domains of Expertise:- Software as a Medical Device (SaMD): Development and verification lifecycle compliant with IEC 62304.- ISO 13485 Conformity: Expertise in aligning processes and systems with ISO 13485 standards for medical device quality management.- Electronic QMS Management: Experience managing eQMS for medical device manufacturers.- Medical Device Documentation Gap Analysis: Conducting gap analyses to ensure compliance with standards.- AI and LLM Integration: Integrating AI and LLM into company operations for efficiency and change management using CustomGPT and AI agents.- Genomic Information Processing: Pioneer in MPEG-G (ISO/IEC 23092); expertise in Samtools and GATK.- Data Compression and Transmission: Proficient in genomic data compression and video compression standards like MPEG-AVC/H264.- Data Visualization & Analytics: Skilled in D3JS and various charting libraries for data analysis.- Web & Software Development: Python for backend, JavaScript frameworks such as ReactJS for the front end.My technical skills are supported by proficiency in project management tools like Jira and Confluence, ensuring efficient project delivery and team collaboration. My career is marked by a relentless pursuit of excellence and innovation in software architecture and IP management, consistently delivering high-quality solutions in the tech industry.