Building and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch...
December 21, 2020 Medical Devices
The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future devel
September 21, 2020 Medical Devices
Medical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In this rapid development scenario, to aid medical device manufacturers, notified bodies, and other stakeholders align with the sophistication and globalization, Regulatory bodies are parallelly revamping the compliance standards.