Angela Serna De Fex

I am a Quality & Regulatory Management consultant focused on helping MedTech, HealthTech, and digital health startups build the right level of structure for their stage.

My work is highly focused on strategic quality and regulatory direction, company structure, operational readiness, and the implementation of practical management systems aligned with ISO 13485, ISO 9001, and ISO 27001. I help companies understand what is required now, what can wait, and how to build a scalable foundation without overengineering.

I have strong experience with SaMD and software-driven products, including product development documentation, design controls, risk management, usability, software lifecycle processes, supplier controls, audits, training, management review, and eQMS implementation. I have also worked from a regulatory standpoint with FDA pathways (510(k), Q-Sub, Breakthrough), Health Canada, EU MDR, LATAM regulatory frameworks, and other international requirements.

I have supported multiple companies through ISO 9001 and ISO 13485 implementation and certification activities, and I have worked with teams across the United States, Europe, Latin America, and Asia.

I really enjoy working with early-stage and growing startups that are building meaningful technology and need quality, regulatory, and information security systems that actually make sense for where they are right now and where they’re trying to go. I take a very supportive and educational approach with teams that are new to quality and regulatory requirements, and I enjoy mentoring them, explaining the “why” behind the requirements, and helping them build knowledge that is practical, sustainable, and useful over time.