Sara Z.

I’m a Regulatory, Quality, and Human Factors Engineering consultant, and I work with medical device companies of all sizes to support product development and navigate complex global regulatory pathways. My goal is to help you streamline the process from concept to market—ensuring your device meets all regulatory, quality, and usability requirements. One of the core services I offer is strategic regulatory support for submissions to the US FDA (510(k)), Health Canada, and the EU MDR. I provide end-to-end guidance—from regulatory strategy and documentation to risk management and usability engineering—ensuring alignment with key standards like FDA Human Factors Guidance, IEC 62366-1, ISO 14971, and ISO 13485:2016. In the Human Factors space, I focus on applying user-centered design principles to reduce use-related risks and improve device safety and effectiveness. I’m experienced in usability testing, use error analysis, and creating robust usability engineering files. In the Quality domain, I assist clients in building and maintaining ISO 13485:2016-compliant Quality Management Systems. Whether you're starting from scratch or improving an existing QMS, I provide practical solutions tailored to your business stage and regulatory goals. Whether you need help preparing a regulatory submission, implementing a compliant QMS, or integrating human factors engineering into your development process, I offer turnkey support and strategic insight to help your team accelerate time-to-market and stay compliant across global markets.