DEVELOPMENT

Bio-Techne (formerly Bionostics) provides a wide array of development services to support individual projects or commercial product introductions. Our partners range from startups to established organizations with new product development needs. We can provide complete product development and manufacturing sourcing or supplement customers' internal capabilities. Our core competencies include:

Quality control: Our stringent formulation and quality testing processes ensure lot-to-lot consistency of our solutions, which is critical for their use as standards for test or sensor development work, or quality control in manufacturing environments. As commercial quality control materials, our solutions are optimized for superior performance and stability in the point-of-care test environment. All development and commercial production is performed in compliance with US FDA QSRs and European 98/79 EC.

Regulatory: The Bio-Techne (formerly Bionostics) regulatory staff generate and submit 510(k)s to the US FDA for the products we develop and manufacture, and assist our customers with generation of technical files for CE marking and other regulatory needs. Our quality system is certified to ISO/CAN 13485:2003 and ISO 9001:2008 and conforms to the requirements of US FDA 21 CFR Part 820 and 98/79 EC for IVD. For more information, please visit the FDA website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

R&D: Bio-Techne (formerly Bionostics) research and development scientists create products that are designed to meet your specific performance requirements. Our product development capabilities are augmented by a range of technical services and distribution alternatives. Whether you require assistance with formulation, artwork, testing, packaging or distribution, Bio-Techne (formerly Bionostics) is able to provide a solution.