Second consecutive year StarFish Medical completes FDA registration
VICTORIA, British Columbia (December 27, 2013) – StarFish Medical announced successful completion of FDA establishment re-registration in December 2013. The FDA requires contract manufacturers to register their facilities in addition to individual devices. This is the second year that StarFish Medical completed its Medical Device Establishment FDA Registration in support of contract manufacturing for Zephyr Sleep Technologies, a company that develops, manufactures and sells medical devices that improve the treatment for obstructive sleep apnea (OSA).
“StarFish Medical’s quality system meets the requirements of CFR 21 Part 820, the Quality System Regulations specified by the FDA” according to Vesna Janic, Director of QA/RA of StarFish Medical. “FDA has a new requirement that contract manufacturers have to register their establishments. Along with our earlier ISO 13485: 2003 Lead Auditor certifications, this FDA registration underscores our commitment to Quality Management Systems and delivering regulatory success for our North American clients and their medical devices.”
Jason Dolynny, Director of Manufacturing notes: “Medical Device Establishment FDA Registration for our contract manufacturing enables our Canadian and US clients to ship FDA registered products directly into the US market to their distributors without taking physical possession of the products. Combined with our class 100,000 clean room and certified Class 100 Laminar Flow Hoods, we are poised to handle all types of assembly and manufacturing of complex electro-mechanical medical devices. ”
About StarFish Medical
StarFish is a leading Medical Device service provider of design, development, and manufacturing services. We partner with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including Digital Health, Microfluidics, and Ultrasound. Medical device product definition, technical engineering and product development use our proprietary PathFinder™ process. Prototype and volume production are delivered in an ISO 13485 certified facility with FDA registration and class 100,000 clean room capabilities.
Our ISO 13485 consultants provide technical regulatory assistance for FDA and Health Canada submissions (including IEC 60601). And our QMS-in-a-Box solutions deliver an effective and affordable Quality Management System that establishes a clear commitment to medical device regulatory compliance for client companies.
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