Strategic Product Development and Market Positioning

Looking to streamline product development while meeting regulatory standards?

My approach focuses on creating a streamlined, compliant development process that aligns with long-term business goals. For start-ups, this means not only building a product but ensuring it is positioned for success in a competitive market.

• User-Centric Design and Requirement Translation: I help define and prioritize user needs, translating them into precise technical and regulatory requirements. This approach not only accelerates development but ensures products meet end-user expectations and regulatory standards from the start.

• Regulatory Pathway Planning and Documentation: Leveraging experience in ISO13485 and 62304 standards, I build comprehensive traceability matrices and guide start-ups through essential compliance steps, significantly reducing risk in the regulatory approval process.

• Operational Efficiency through Project Management: With expertise in both classical waterfall and agile project management, I tailor project workflows to meet both strategic and operational needs, enhancing productivity and optimizing resource allocation.