Austin, TX, October 29, 2014 – Corvalent announced today that once again it has achieved a major milestone by receiving ISO13485-2003 re-certification. ISO 13485-2003 is an international ISO standard that defines the requirements for a comprehensive management system for the design and manufacture of medical devices.
Ana Rudloff, Quality Assurance & Doc Control Specialist stated, “It is very rewarding to achieve ISO13485:2003 certification. Our continuing success passing surveillance audits without any corrective actions just confirms the well-designed and implemented Quality System at Corvalent”.
She adds, “Our entire team has become self-aware and motivated to the highest quality standards. It is an effort we are all very proud of. Striving and pushing ourselves to achieve the highest levels of operational excellence in serving our customers.”
“What I am mostly proud of is that what ISO means to us as an organization is true compliance of ISO standards and not just a certification. Many companies in the world do the minimum possible to get certification and they are not necessarily fully compliant to the standards.” said Ed Trevis, President and Chief Executive Officer. “Being fully compliant 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 product realization process for our customers.”
Corvalent has a long history and experience with the medical OEM equipment industry, providing products and services for more than 20 years. Adding ISO13485 certification a few years ago enabled our company to expand products and contract manufacturing services to medical equipment customers, providing product development and full turn-key manufacturing”.
He further added, “We are committed and even exceed Medical Equipment customer requirements, including product design, manufacturing, and long life product cycle management.”
ISO13485 is generally harmonized with ISO 9001 but ISO 13485 requires organizations to demonstrate that quality systems are not only effectively implemented, but also maintained and demonstrate continuous improvement. ISO13485 also requires, but is not limited to the following:
- 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
ISO13485-2003 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 and guarantee seven to ten year consistent long-life supply in production. Corvalent Industrial PC-based x86 platform integration 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.
You can rest assured that we will continue to make every necessary change to always stay on the leading edge of quality and performance for our clients. ISO Certifications is only a standard. Exceeding expectations means delivering products and services than keep our clients running without concerns and the tools to keep customers leaders in their respective industries.