California-based company adds quality management certification to existing FDA registration and pharmacy licensing for lab testing kit fulfillment operations.
The Dot Corp has earned ISO 9001:2015 certification, adding another regulatory credential to support its healthcare fulfillment operations that include lab testing kit distribution and medical device logistics.
The Irvine, California-based company already operates as a US Food and Drug Administration-registered facility and holds licensing as a Wholesaler from the California State Board of Pharmacy and as a Licensed Medical Device Manufacturer from the California Department of Public Health, Food and Drug Agency.
The ISO certification covers The Dot Corp’s fulfillment services for diagnostic laboratories, healthcare systems, payers, and medical device companies requiring regulated product distribution at scale.
“This milestone is more than a quality stamp. It’s a validation of the systems, people, and precision we’ve built to support the healthcare industry,” says Jeff Shattuck, CEO of The Dot Corp, in a release. “Whether it’s kitting for lab tests or fulfilling medical devices across the country, our clients rely on us to deliver with speed, accuracy, and full regulatory compliance.”
Quality Management for Lab Operations
The ISO 9001:2015 standard establishes requirements for quality management systems, focusing on consistent delivery of products and services that meet customer and regulatory requirements. For clinical laboratories and diagnostic companies, working with ISO-certified fulfillment partners can support their own quality assurance programs and regulatory compliance efforts.
The Dot Corp’s services include fulfillment operations for lab testing programs, medical device distribution, and regulated healthcare product logistics. The company provides nationwide capabilities for diagnostic laboratories requiring secure chain of custody for specimen collection kits and testing materials.
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