“The Ohio State University Wexner Medical Center is striving to become a zero-waste campus by 2025 (i.e., 90% diversion of non-hazardous waste away from landfills) through an economically sustainable waste diversion program. To make progress towards this ambitious goal within a three-year deadline, the medical center must rapidly ramp up its waste diversion and waste prevention practices.”

“The US Food and Drug Administration (FDA) is working to finalize its proposal to align its device Quality System Regulation (QSR) with the international standard ISO 13485:2016, creating the Quality Management System Regulation (QMSR). In preparation for the final rule, the agency is readying for the change internally by updating its technology systems, training staff and replacing the Quality System Inspection Technique (QSIT). “If you’ve ever seen a 483 form, list of observations about inspections, you know that we have databases from which we pull citations and observations that are connected to the regulation, the current [21 CFR Part] 820. So, all of that has to change,”

"The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations involving drugs, biologics and medical devices. The question-and-answer format document states that “clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned. This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.”

“Medical device manufacturers with products on the U.S. market need to remember to seek FDA’s blessing when a previously cleared device is significantly modified. It’s a lesson that London, England-based Medivance Instruments is learning the hard way. The company holds a 510(k) clearance for its Velopex Aquacut Fluid Abrasion Unit, a device intended for use in a range of dental procedures. However, according to a recent FDA warning letter to Medivance Instruments, the Velopex device has been significantly modified in multiple ways since it was cleared in 2003.”