MedTech Member, Praxis Technology, Achieves ISO 13485 Standard for Design and Development
Thursday, May 13, 2010
Praxis Technology Inc. announced today that it successfully achieved ISO 13485 certification for design and development of medical devices from TUV Rheinland Management, reinforcing its leading position in the competitive medical device market.
Praxis Technology has been ISO 13485 certified for manufacturing of medical devices since June 2009. The design and development certification means that Praxis Technology has met additional requirements that allows for the building of a design history file for devices and processes, adding data as products progress through various development stages. This additional capability provides Praxis’ customers with both speed and quality necessary to maintain a competitive advantage in today’s complex healthcare landscape.
“This certification is a world-class credential, and it reflects the innovation and efficiency that makes Praxis a truly world-class team in process and product development,” said Joe Grohowski, president and CTO of Praxis Technology.
ISO 13485 is an international standard for quality management systems in the medical device industry.
In addition to maintaining ISO 13485 quality systems certification, Praxis Technology also complies with current good manufacturing practice (cGMP) standards.
Praxis Technology is a primary member of MedTech, the trade association that supports the growth and development of biomedical and pharmaceutical businesses in Upstate New York.
For more information about Praxis Technology, Inc., contact Tracy MacNeal, (518) 812-0112.
ABOUT PRAXIS TECHNOLOGY, INC.
Founded in 1999, Praxis Technology’s unique, proprietary methods of manufacturing via powder titanium allow for the rapid, cost-effective launch of groundbreaking titanium implants. Areas of application include orthopedics, cardiac, vascular access, spine, prosthetics, and dentistry. Praxis provides innovative solutions to the most sophisticated device manufacturing challenges, including licensing arrangements, R&D prototype development and full scale manufacturing. For more information, visithttp://www.praxistechnologyinc.com/.
MedTech is a not-for-profit trade association that promotes the commercialization of medical products by providing educational and networking events, organizing certification opportunities and facilitating collaborations among members to bring tomorrow’s technologies to the healthcare marketplace. Learn more athttp://www.medtech.org.