Heart Valve Testing Specialists, Vivitro, Granted Accreditation ISO/IEC 17025:2005 by American Association for Laboratory Accreditation (A2LA)
Published: Jan 25, 2012
The accreditation confirms ViVitro Labs commitment to meeting the highest quality standards and regulatory requirements to perform testing on heart valves to the ISO 5840 standard. The increasing challenges and demands on medical device manufacturers to evaluate heart valves for haemolytic and thrombogenic potential by assessment of flow fields, to determine hydrodynamic performance and assess durability have never been so achievable.
Medical devices are subject to the some of the highest governmental regulations. “By recognizing a single quality benchmark, ISO 17025 provides a highly recognized global standard for laboratory testing compliance,” states David Mester, General Manager of ViVitro Labs, “We welcomed the opportunity to prove our compliance, believing that should be a basic tenet for all in our industry, and we’re pleased that A2LA has recognized our quality system.”!
ViVitro Labs has taken the first step to harmonizing ISO standards by applying a more rigorous and uniformed standard for competence of testing for the assessment of heart valve replacements including transcatheter heart valves governed by the ISO 5840 standard.
About ViVitro Labs
ViVitro Labs Inc. offers industry leading prosthetic heart valve test equipment and laboratory testing, consulting and engineering services. For over 25 years, ViVitro has been known as a trusted source of quality devices and services that empower our clients to carry out world-leading research, develop innovative products, and demonstrate regulatory compliance.
Distribution in China is available.
For more information, please contact ViVitro Labs: