The Food and Drug Administration recently named Orion Registrar Inc. a member of its Inspection by Accredited Persons Program (IAP).

The designation will let Orion Registrar perform federally mandated product safety and quality system inspections of eligible medical-device manufacturers. Orion also offers clients the ability to integrate their FDA inspection and European CE Mark audits into a single assessment, saving time and resources.

The IAP program was authorized by the Medical Device User Fee and Modernization Act of 2002. It authorizes accredited parties such as Orion Registrar to conduct medical device facility inspections, assess the quality systems of manufacturers of Class II and Class III devices under FDA 21 CFR Part 820, determine compliance with other device requirements in the act and regulations, and prepare and submit reports to the FDA, which makes the final compliance assessment.

“This is a tremendous day for Orion,” says Paul Burck, Orion Registrar president. “Many companies are more comfortable with a small customer service-driven registrar than they are with the FDA or a huge international corporation.”

Orion Registrar can be found on the Web at www.orion4value.com.

 …