Boxborough, Massachusetts – Invetech, a full-service provider specializing in the design, development and manufacturing of clinical diagnostic instruments, point of care devices and configured systems for cell and gene therapy manufacturing, today announced it has completed registration with the U.S. Food and Drug Administration (FDA) as a contract manufacturer of IVD and life science instruments for its Boxborough, Massachusetts facility.
This achievement follows the company’s ISO 13485 certification, which saw Invetech expand its global IVD contract manufacturing footprint into the United States while complementing the well-established manufacturing capabilities of its facility in Melbourne, Australia.
In addition to its FDA registration and IVD instrument manufacturing accreditation, the Boxborough facility will continue to operate as an ISO 9001 accredited design and manufacturing center for the supply of subsystems for diagnostics instruments and precision motion solutions. Co-located with Invetech’s U.S. contract manufacturing business at the facility is its Dover Motion division, a leading provider of precision stages and engineered motion solutions for the medical, life sciences, and diagnostics industries.
Invetech’s product design and development services are complemented by in-house contract manufacturing offering, providing its clients with a single point of accountability throughout the entire product realization process.
“Invetech’s registration with the FDA is an exciting milestone, and we fully embrace the responsibility to continuously provide high-quality IVD and life science instruments to our clients in the United States as well as globally,” said Andreas Knaack, President of Invetech. “We have been supporting diagnostics clients including Abbott, Bio-Rad and Haemonetics with the manufacturing of their devices for many years, and the registration solidifies our long-term commitment to the market.”
“Leveraging our culture of Kaizen, the Fortive Business System and our global supply chain allows us to provide a superior service to our contract manufacturing clients. The Boxborough facility provides a great opportunity to manufacture IVD instruments domestically, particularly for those clients who wish to repatriate their products in light of recent COVID-19 related learnings.”