January 25, 2012 (Victoria, B.C.) ViVitro Labs Inc., a global provider of
cardiovascular device testing equipment and laboratory services, announces
that its Laboratory Services headquartered in Victoria, B.C. has been
accredited by the American Association for Laboratory Accreditation (A2LA)
to perform Laboratory testing for ISO 5840 Cardiovascular Implants - Cardiac
Valve Prostheses Annex L and M in accordance with ISO/IEC 17025:2005,
the most recognized standard for competence of testing in the industry.
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
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
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: