Standardized assays are just the beginning of what Innovotech has to offer. While standard assays provide an excellent way to compare different products and formulations, and allow for the generation of reproducible results between laboratories, they rarely take into account the conditions that a product will be exposed to while in use. Increasingly, regulatory agencies want to see testing performed under conditions that mimic real world scenarios. With 40+ years of collective microbiology experience, we specialize in developing platforms to reproducibly test finished medical devices. Our experience includes testing for catheters (CVC and PICC), urinary stents/catheters, endotracheal tubes, guide wires and leads, cannulae, stents, ports, luer fittings, needles, implants, pins, ostomy bags, site scrubs, textiles, masks, filters, and wound dressings. Our laboratory is certified by CALA to ISO/IEC17025 (testing accreditation number A4146 for Enumerating Bacteria –Solids and Enumerating Bacteria –Liquid), providing the necessary confidence in our results for use in regulatory submissions.
