FDA Site Registration
Argonaut Manufacturing Services is proud to announce their registration with the Food and Drug Administration as a medical device establishment.
The registration follows an earlier certification of ISO 13485:2016 as Argonaut Manufacturing Services continues to expand it’s manufacturing and operational capabilities.
Registering with the FDA “together with our ISO 13485:2016 certification demonstrates our on-going commitment to providing our clients the highest level of quality and regulatory compliance,” said Leigh Amini, Argonaut’s Director of Quality. “This is especially critical as the regulatory environment for the medical device and molecular diagnostic industries continues to evolve.”
About Argonaut Manufacturing Services
Argonaut is an independent contract manufacturing organization dedicated to providing manufacturing and supply chain solutions for life science, MedTech and molecular diagnostic companies. With the recent completion of 11 state-of-the-art manufacturing cleanroom suites located within their 31,000 square foot facility, Argonaut is providing flexible solutions for their clients diverse outsourcing needs.