Press Release

StarFish Medical adds ISO 13485: 2003 Lead Auditors, reactivates FDA registration

August 12, 2013

StarFish Medical adds ISO 13485: 2003 Lead Auditors,

Reactivates FDA registration for contract manufacturing of FDA cleared products

VICTORIA, British Columbia, August 12, 2013 –

StarFish Medical announced three key staff members have earned Lead Auditor ISO 13485: 2003 certification.  The awards supplement current StarFish Medical ISO 13485 certification for product development and manufacturing held since 2004. StarFish Medical also announced FDA registration was reactivated for its manufacturing facility to better support contract manufacturing products sold in the USA.

The actions are part of StarFish Medical’s strategic direction of enhancing medical device design and manufacturing process improvements and personal development.  Jason Dolynny, Director of Manufacturing, Vesna Janic, Director of QA/RA, and Cameron Neish, QA Specialist, all completed training and certification.

The training gives StarFish Medical staff’s deeper knowledge of ISO 13485: 2003, helps them gain an Auditor’s perspective, and adds focus and detail at the audit level to StarFish Medical processes and systems.

StarFish’s quality system is certified to ISO 13485 and has always included the additional requirements of CFR 21 Part 820, the Quality System Requirements specified by the FDA” according to Vesna Janic, Director of QA/RA of StarFish Medical.  “The ISO 13485: 2003 Lead Auditor certifications and FDA registration underscore 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: “Including Manufacturing Management in certification helps ensure quality is not just part of a review process, but part of StarFish Medical DNA.  FDA registration as a contract manufacturer 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.”

About StarFish Medical

StarFish Medical is a boutique Medical Device Design company with a full complement of design, development, and manufacturing services. Using the PathFinder Process, product definition, technical engineering, product development, prototype and volume production are delivered in an ISO 13485 certified and FDA registration environment. StarFish Medical helps clients solve the right problem with a multi-disciplinary team of engineers, physicists, and industrial designers who successfully navigate regulatory hurdles for clients across North America. For more information please contact: Mike Camplin.



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