Millstone Medical Outsourcing Expands Testing Services
Millstone Medical Outsourcing has announced a significant enhancement in its leadership by appointing Michael Quin as the Senior Director of Laboratory Services. This strategic move aligns with the company's commitment to improving and expanding testing services for global medical device original equipment manufacturers (OEMs). With the healthcare industry evolving, this hire showcases Millstone's resolve to drive innovation in medical device testing.
Achievements in Testing Facilities
Quin’s appointment builds upon Millstone's recent accomplishments, particularly the inauguration of a new, expansive ISO 17025-certified testing facility. This facility, which spans 25,000 square feet, represents a milestone in Millstone's journey toward enhancing its laboratory capabilities. Such expansions promise not only increased capacity but also faster turnaround times and the introduction of new testing services that are currently being considered.
Expertise That Transforms
Bringing over 25 years of diversified experience in the medical device and pharmaceutical sectors, Michael Quin is well-prepared to take on this new role. His impressive career includes 17 years with DePuy, a division of Johnson & Johnson, where he honed his expertise in sterility assurance and product development. Furthermore, his contributions to leading companies such as Amgen and Medtronic have equipped him with a wealth of knowledge necessary for overcoming challenges related to microbiology and contamination control.
Industry Leadership and Regulatory Landscape
Karl Neuberger, the CEO of Millstone, expressed confidence in Quin’s capability to drive the company's vision forward. As regulation intensifies, manufacturers face heightened expectations surrounding product compliance and testing speed. Millstone is dedicated to ensuring its testing services lead the industry in quality and efficiency, and Quin is the right person to guide this initiative.
Strengthening Patient Safety
Quin believes that Millstone represents a unique opportunity for innovation within the medical device landscape. He noted the company’s commitment to investing in comprehensive testing solutions that encompass packaging and logistics, providing OEMs with exceptional value. The firm's integrated approach supports product development directly, refining sterility assurance processes and ultimately enhancing patient safety through reliable equipment.
Importance of Compliance and Quality
Given the increasing demands for compliance under FDA QMSR and EU MDR regulations, the necessity for well-validated sterility and performance testing cannot be overstated. Millstone's investment in testing capabilities is not just a response to industry demands; it reflects a proactive approach to risk management, assuring OEMs of high-quality solutions that streamline their operations and reduce market entry times.
About Millstone Medical Outsourcing
Millstone Medical Outsourcing is recognized as a premier provider of tailored outsourcing solutions for the medical device industry, servicing over 50 well-established companies, particularly in orthopedics. The firm emphasizes quality service alongside expertise, ensuring clients receive a guaranteed return on investment. Offering a range of services including advanced inspection and sterile packaging, Millstone operates cutting-edge facilities to meet the global needs of device and product manufacturers.
The company is privately held and maintains its compliance with FDA regulations, while also holding ISO certification by BSI, Inc. under ISO 13485:2016 standards. With robust operations in Fall River, MA, and Olive Branch, MS, Millstone is positioned to provide exemplary service to its clients worldwide.
Frequently Asked Questions
What role does Michael Quin play at Millstone Medical?
Michael Quin has been appointed as Senior Director of Laboratory Services, focusing on enhancing testing services.
Why is Millstone expanding its testing services?
Millstone is expanding to meet the growing demands of regulatory compliance and improve service delivery for medical device OEMs.
What experience does Michael Quin bring to Millstone?
Quin brings over 25 years of experience in the medical device and pharmaceutical industries, with expertise in sterility assurance and microbiology.
How does Millstone ensure quality in its services?
Millstone utilizes comprehensive testing and inspection processes, along with adhering to industry standards such as ISO 13485:2016.
What types of services does Millstone provide?
Millstone provides services including sterile packaging, inspection, and distribution, along with advanced testing solutions for its clients.
