As the Director of Quality Assurance and Regulatory Affairs at United Safety Technology (UST), Larry Ludensky plays a pivotal role in the company's mission to restore and enhance PPE manufacturing within the United States. With extensive expertise in regulatory frameworks such as EU MDR, MDSAP,...
As the Director of Quality Assurance and Regulatory Affairs at United Safety Technology (UST), Larry Ludensky plays a pivotal role in the company's mission to restore and enhance PPE manufacturing within the United States. With extensive expertise in regulatory frameworks such as EU MDR, MDSAP, and ISO standards, Larry is instrumental in ensuring that UST's products meet the highest quality and safety standards. His deep understanding of Good Manufacturing Practices (GMP) and quality systems enables him to oversee critical processes, including New Facility Commissioning, Auditing, and Risk Management, thereby safeguarding the integrity of the manufacturing operations.
Larry's leadership in managing the complaint process and complaint file management is crucial for maintaining customer trust and satisfaction. His proactive approach to Change Control and Corrective and Preventive Actions (CAPA) ensures that any issues are swiftly addressed, fostering a culture of continuous improvement throughout the organization. By leveraging his skills in Project Management and Supply Chain Management, Larry effectively coordinates cross-functional teams to streamline operations and enhance product quality.
Currently, Larry is spearheading key projects aimed at bolstering the resiliency of the U.S. healthcare supply chain, particularly in the face of global challenges. His commitment to excellence and regulatory compliance not only positions UST as a leader in the PPE sector but also contributes significantly to the safety and security of Americans. With a focus on innovation and quality assurance, Larry Ludensky is dedicated to driving UST's vision forward, ensuring that lifesaving PPE products are manufactured to the highest standards right here in the USA.
