development & commercialization

Regulatory Services

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 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