Corvalent Achieves ISO 13485:2003 Certification for the Design and Manufacture of Medical Devices
Austin, TX, December 18, 2012 – Corvalent, the only embedded computing design and manufacturing provider to assure a minimum of seven years product longevity, announced today that it achieved a major milestone by receiving ISO13485 certification. ISO 13485 is an international ISO standard that defines the requirements for a comprehensive management system for the design and manufacture of medical devices.
“We are proud to not only achieve recognition as an ISO 13485-certified company, but we are also 100 percent compliant with the quality criteria required by this medical device manufacturing standard,” said Ed Trevis, president and chief executive officer of Corvalent. “Being certified allows us to become a one-stop partner for all design and manufacturing of medical device equipment using computing technology. We will expand our medical equipment OEM relationships by providing innovative, revision-controlled, medical-grade products and by managing more of the process for our customers.”
Corvalent has a long history and experience with the medical OEM equipment industry, providing products and services for more than 19 years. By adding ISO 13485 certification, the company plans to expand its existing medical equipment supplier customer base and add new customers who want to consolidate their number of manufacturing vendors.
“The results of our ISO 13485 audit found neither major nor minor non-conformances during the audit and certification process,” continued Trevis. “Corvalent’s quality system was found to be faultless. We are committed to a high quality design and manufacturing process that meets, and even exceeds, medical OEM community requirements, including product design, manufacturing, and long life cycle management.”
About ISO 13485
ISO 13485 is generally harmonized with ISO 9001 but ISO 13485 requires organizations to demonstrate the quality system is not only effectively implemented, but also maintained to demonstrate continual improvement. ISO 13485 also requires the following, but is not limited to the:
- promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR Part 820 Quality System Regulation for Medical Devices sold in the United States.
- controls in the work environment to ensure product safety
- focus on risk management activities and design control activities during product development
- specific requirements for inspection and traceability for implantable devices
- specific requirements for documentation and validation of processes for sterile medical devices
- specific requirements for verification of the effectiveness of corrective and preventive actions
ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF). The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices.
Founded in 1993, Corvalent is the only embedded computing design and manufacturing provider to deliver long-life products, long-term cost savings and lasting relationships with customers, partners and employees. Corvalent is the only provider to deliver ten year product longevity. Corvalent’s x86 platform has a proven track record of providing robust Intel-based solutions for industrial applications, including oil and gas, industrial automation, defense/military, automotive, mobile/rugged, security and surveillance, and medical applications. As a single source delivering industrial design through full-scale manufacturing, Corvalent offers flexibility and growth through turnkey solutions, including rack mounted systems, mobile/handheld devices, embedded motherboards, embedded systems, and industrial display systems.