Primary industry: Biotechnology | Secondary industry: Manufacturing
Hi! I help startups move from idea to market with a practical, hands-on approach. Over the past year, I supported a biotech/medical device company in building its operations from the ground up—establishing quality systems, setting up manufacturing, and guiding it through a successful ISO 13485 certification for a Class II medical device. My background blends quality assurance, regulatory affairs, and commercialization, with working knowledge across ISO 9001, ISO 13485, and ISO 17025 frameworks. I understand the challenges founders face when “they don’t know what they don’t know,” and I enjoy breaking down complex regulatory and quality requirements into clear, actionable steps. Whether it’s preparing for export markets in Canada, the U.S., or abroad, designing a compliant quality management system, or aligning R&D with commercialization strategy, I focus on helping early-stage companies get started the right way. My goal is to give founders confidence, speed, and structure so they can scale sustainably and focus on their core innovation.