Pittsburgh, Pennsylvania ̶ March 2012 ̶ Oberg Medical, a full-service Medical Device contract manufacturer providing implants, instruments and assemblies, proudly announces its recent certification to ISO 13485:2003.
“The achievement of ISO 13485 certification reinforces the commitment we have to our OEM partners and the medical device market. During the past year we have completed the IQ and OQ validation of all of our manufacturing equipment and the IQ/OQ/PQ validation of our internal special processes,” said David Bonvenuto, Executive VP and General Manager of Oberg Medical. “Our quality Management System is the core of our
business. When you compliment that with our risk management, program management and design for manufacturability processes and focus ̶ the result is a contract manufacturer that can effectively and efficiently work on new product launches and program transfers to deliver results.”
Oberg has a wholly-owned subsidiary in San Jose Costa Rica (established in 2002) that currently employs over 100 employees and maintains ISO 9001 certification. Bonvenuto added, “Our Costa Rica operation is a vital part of our medical growth strategy. We look to complete ISO 13485 certification for this facility and continue to have it be an extension of our Pittsburgh, PA operations.”
About Oberg Medical
Oberg Medical is accelerating the performance of medical device outsourcing. As a $110 million organization with over 700 employees worldwide, Ob erg Medical is one of the primary sources that OEMs are calling on to support their own growth and vendor consolidation initiatives.
Oberg Medical is unique in its equipment capability and capacity footprint. Oberg has a “Triple Double” in terms of having over 50 stamping presses (5-400 ton capacity) with over 30 multi-axis mills and over 30 wire and sinker EDMs. This unique manufacturing footprint allows Oberg to provide metal and plastic implants, instruments and complex assemblies for a variety of medical device segments with a targeted focus on Orthopedic, Spine, Extremity, Endoscopic/Laparoscopic and Cardiac Rhythm Management markets.