“If you can’t fly, then run. If you can’t run, then walk. If you can’t walk, then crawl, but by all means, keep moving.” – Dr. Martin Luther King Jr.

Fritzner Laurent is a seasoned professional in the medical device industry with over a decade of experience specializing in quality systems, regulatory compliance, supplier quality, and manufacturing processes. With a background in Bioengineering and Biomedical Engineering from the University of Massachusetts Dartmouth, he has dedicated his career to ensuring the highest standards in medical technology, regulatory adherence, and operational efficiency. His expertise spans across major medical device companies, including Stryker, DePuy Synthes, Boston Scientific, and Smith & Nephew, where he has played pivotal roles in implementing European Medical Device Regulation (EU MDR) compliance and supplier quality improvement initiatives.

As a Staff Supplier Quality Engineer at Stryker, Fritzner has successfully managed and executed supplier quality tasks critical to EU MDR compliance, working closely with global suppliers to meet stringent regulatory requirements. His contributions include implementing Unique Device Identification (UDI) direct part marking, managing technical file reviews, and overseeing supplier documentation to ensure compliance with international standards. His ability to bridge the gap between suppliers and regulatory expectations has made him a vital asset in the industry.

Prior to his tenure at Stryker, Fritzner served as an EU MDR Manufacturing Quality Engineer at DePuy Synthes, where he performed critical gap analyses on manufacturing processes and quality procedures. He collaborated with cross-functional teams, including Regulatory Affairs and R&D, to transition products to full EU MDR compliance. His leadership in coordinating site-wide EU MDR activities ensured smooth transitions and regulatory submissions, highlighting his ability to navigate complex compliance landscapes.

Fritzner’s expertise extends beyond compliance and supplier quality. His role as an EU MDR Supplier Quality Engineer at Boston Scientific allowed him to assess supplier capabilities, conduct audits, and implement corrective actions. His ability to work seamlessly with internal teams such as labeling, regulatory, and marketing further underscores his strategic approach to quality assurance. His work has directly impacted product specifications, change implementations, and supplier alignment with regulatory requirements.

Earlier in his career, Fritzner honed his skills in complaint investigations and failure analysis at Mitek Sports Medicine. As a Complaints Quality Engineer, he led failure analyses, collaborated with medical safety teams, and conducted intensive product family complaint reports for the European Union. His experience in root cause analysis, corrective action implementation, and regulatory reporting further solidified his standing as a quality and compliance expert.

Beyond his professional roles, Fritzner has led significant engineering and research projects, showcasing his innovative thinking and technical expertise. His work on gel capacitors mimicking muscle movement and the design of a laser-based surgical cutting tool demonstrates his commitment to advancing medical technology. He has also built a functional ECG device and contributed to the development of an underwater ROV, reflecting his strong engineering acumen and problem-solving capabilities.

Fritzner is not only a leader in the medical device industry but also an advocate for global change. As the President of Operation Help Now (OHN) since 2012, he has led initiatives to raise awareness of underrepresented global issues. He is also actively involved in professional organizations, including the National Society of Biomedical Engineering (BMES), Engineers Without Borders (EWB), and the National Society of Black Engineers (NSBE), where he has served as Secretary and Treasurer. His involvement in these organizations highlights his dedication to advancing biomedical engineering, sustainability, and community-driven development.

Fluent in English and Haitian Creole, Fritzner possesses strong cross-cultural communication skills, enabling him to collaborate effectively with global teams and stakeholders. His ability to lead supplier negotiations, manage compliance projects, and align quality standards across international operations has made him a sought-after expert in his field. His professional endorsements in strategic planning, leadership development, and regulatory affairs further attest to his ability to drive meaningful change in the industry.

With his extensive experience, strategic insight, and leadership in quality and regulatory affairs, Fritzner Laurent is well-positioned to contribute to board and advisory roles in the medical device industry. His passion for improving healthcare technology, combined with his expertise in compliance and supplier quality, makes him an invaluable asset to organizations seeking to navigate the complexities of global regulations while ensuring the highest standards of quality.

Character:
Fritzner Laurent is a highly motivated and passionate professional with a strong commitment to problem-solving, continuous improvement, and innovation in the medical device industry. His leadership in quality assurance and regulatory compliance reflects his dedication to upholding the highest standards in healthcare technology.

Knowledge:
With expertise in EU MDR compliance, supplier quality, failure analysis, and risk management, Fritzner has a comprehensive understanding of medical device regulations and quality systems. His technical background and hands-on experience in engineering projects further enhance his ability to drive innovation and compliance.

Strategic:
Fritzner has a proven ability to navigate complex regulatory landscapes, streamline supplier quality initiatives, and implement process improvements that enhance product compliance. His strategic approach to quality assurance ensures companies remain competitive while meeting stringent regulatory demands.

Communication:
As a multilingual professional fluent in English and Haitian Creole, Fritzner excels in cross-functional collaboration, supplier negotiations, and regulatory discussions. His strong leadership and communication skills enable him to effectively convey quality and compliance expectations to stakeholders worldwide.