Richard Wynkoop, as President & CEO of Vision28, leverages his extensive background in quality management and regulatory affairs to drive the organization’s mission of providing pragmatic solutions for the FDA-regulated industry. With a career that spans various roles—from Quality Engineer to Director of Quality Assurance...
Richard Wynkoop, as President & CEO of Vision28, leverages his extensive background in quality management and regulatory affairs to drive the organization’s mission of providing pragmatic solutions for the FDA-regulated industry. With a career that spans various roles—from Quality Engineer to Director of Quality Assurance and Regulatory Affairs—Rich brings a wealth of expertise in navigating the complexities of compliance and quality systems within the medical device sector. His hands-on experience equips him with a unique perspective on the challenges faced by organizations striving to meet stringent regulatory requirements, such as ISO 13485:2016 and 21 CFR Part 11.
At Vision28, Rich leads key projects that focus on enhancing quality management systems and ensuring compliance with both U.S. and international regulations, including those set forth by European Notified Bodies and Health Canada. His strategic approach emphasizes cost-effective solutions that not only meet regulatory standards but also drive operational excellence. Rich’s proficiency in risk management methodologies, such as FMEA and ISO 14971, enables Vision28 to assist clients in identifying and mitigating potential risks associated with their products.
Under his leadership, Vision28 has positioned itself as a trusted partner for organizations navigating the complexities of regulatory submissions and quality assurance processes. Rich’s commitment to fostering a culture of continuous improvement and innovation is evident in the company’s tailored services, which range from comprehensive regulatory support to targeted consulting for specific compliance challenges. His vision for Vision28 is to empower clients to achieve successful outcomes while maintaining the highest standards of quality and safety in their products.
