Matthew Walenciak serves as the Principal Consultant at PACE Medical Device Consulting LLC, where he leverages over 25 years of extensive experience in the medical device industry to drive quality management and operational excellence. His deep-rooted expertise spans various critical areas, including quality systems development,...
Matthew Walenciak serves as the Principal Consultant at PACE Medical Device Consulting LLC, where he leverages over 25 years of extensive experience in the medical device industry to drive quality management and operational excellence. His deep-rooted expertise spans various critical areas, including quality systems development, product development engineering, and manufacturing strategy. At PACE, Matthew is instrumental in helping clients navigate the complexities of regulatory compliance and quality assurance, ensuring that their products not only meet but exceed industry standards.
One of Matthew's key projects involves enhancing quality systems for clients facing challenges in Corrective and Preventive Action (CAPA) processes and documentation control. His strategic approach to quality systems integration and remediation has proven invaluable for organizations seeking to streamline operations and improve overall product quality. Additionally, he excels in audit and inspection readiness, providing comprehensive support for both front and back room management, which is crucial for maintaining compliance during regulatory inspections.
Matthew's proficiency in post-market quality compliance is another cornerstone of his consulting practice. He adeptly manages complaint handling and post-market surveillance, ensuring that clients can effectively monitor and address product performance in the field. His strong engineering background, combined with a thorough understanding of Good Manufacturing Practices (GMP) and FDA regulations, positions him as a trusted advisor for companies striving to enhance their quality frameworks and operational efficiencies. Through his leadership and commitment to excellence, Matthew Walenciak continues to shape the future of quality management in the medical device sector.
