Bionostics is a world-leading developer and manufacturer of high quality, turnkey calibrators and quality control products for original equipment manufacturers (OEMs) for critical care / point-of-care and diabetes diagnostics test systems.
Located in Devens, Massachusetts, Bionostics offers a variety of services to provide high quality, cost effective, turn-key solutions to our customers, large and small. We maintain professional associations with customers and suppliers, striving to work together in relationships that are beneficial for all parties. As a key partner to world-class OEMs, we are acutely aware of our responsibility to maintain and foster the brand identities of our clients.
Our quality systems are certified to ISO 9001:2008 and 13485:2003. Our products are listed as Class I and Class II with the US FDA, bear Class II and Class III Medical Device Licenses in Canada and fully comply with requirements of 98/79/EC, the In-Vitro Diagnostics Directive.