05.01.13
Plastics One has achieved ISO 13485:2003 certification, which certifies that the company satisfies the requirements for a comprehensive management system for the design and manufacture of medical devices. The plastics injection and insert molded components manufacturer also maintains its ISO 9001 certification for its quality management system. Based in Roanoke, Va., Plastics One partners with OEMs and neuroscience researchers for the design, molding and assembly of components and electronics for the medical device industry.
Greenville, S.C.-based AVX Corporation has been awarded ISO 13485:2003 certification for its tantalum capacitor manufacturing facility located in Biddeford, Maine. The company manufactures advanced passive components and interconnect solutions; supplies tantalum capacitors for critical applications; and power supplies for medical devices such as life support and life enhancement systems. AVX Tantalum Corp. General Manager Bob Fairey said the certification is a “valuable tool that will help us continue to manufacture safe, trusted, and high-quality tantalum capacitors for use in critical medical devices.”
Philadelphia, Pa.-based Echo Therapeutics Inc. has gained ISO 13485:2003 certification. The company currently is developing the needle-free Symphony CGM system as a non-invasive, wireless, transdermal continuous glucose monitoring system. “We believe that receiving ISO 13485 certification is a significant accomplishment and an important milestone as we approach the European pivotal trial and commercialization of our Symphony CGM system,” said Stephen Perez, Echo’s vice president of quality assurance.
Bacterin International Holdings Inc., a Belgrade, Mont.-based manufacturer of bone graft material and coatings for medical applications, has been awarded ISO 13485:2003 certification. Bacterin develops, manufactures and markets biologics products within the United States and internationally. The company aims to optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth. Its products are used in applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries. “We look forward to leveraging this certification to further enhance and expand our product portfolio in regenerative medicine,” said CEO Guy Cook
Greenville, S.C.-based AVX Corporation has been awarded ISO 13485:2003 certification for its tantalum capacitor manufacturing facility located in Biddeford, Maine. The company manufactures advanced passive components and interconnect solutions; supplies tantalum capacitors for critical applications; and power supplies for medical devices such as life support and life enhancement systems. AVX Tantalum Corp. General Manager Bob Fairey said the certification is a “valuable tool that will help us continue to manufacture safe, trusted, and high-quality tantalum capacitors for use in critical medical devices.”
Philadelphia, Pa.-based Echo Therapeutics Inc. has gained ISO 13485:2003 certification. The company currently is developing the needle-free Symphony CGM system as a non-invasive, wireless, transdermal continuous glucose monitoring system. “We believe that receiving ISO 13485 certification is a significant accomplishment and an important milestone as we approach the European pivotal trial and commercialization of our Symphony CGM system,” said Stephen Perez, Echo’s vice president of quality assurance.
Bacterin International Holdings Inc., a Belgrade, Mont.-based manufacturer of bone graft material and coatings for medical applications, has been awarded ISO 13485:2003 certification. Bacterin develops, manufactures and markets biologics products within the United States and internationally. The company aims to optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth. Its products are used in applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries. “We look forward to leveraging this certification to further enhance and expand our product portfolio in regenerative medicine,” said CEO Guy Cook