An article collection examining regulations across quality systems, good manufacturing practices, and documentation
Med Device Online’s editorial coverage includes market analysis, device design insights, and pricing/reimbursement strategy. This eBook, though, focuses on our readers’ greatest shared concern: demystifying the constantly evolving regulatory landscape each medical device must navigate before it can help patients. Stemming from a number of sources —the EU’s new Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), attempts to harmonize regulatory standards across the globe, and the rise of emerging markets as product launch and clinical trial destinations, to name a few — regulatory confusion can be time-consuming, costly, and damaging to your brand. This eBook offers a sampling of the clarity Med Device Online can provide.