Quality Management Systems (QMS) certification is the requirement of every business processes who need to comply with an arrangement of complex and challenging regulatory requirements. Operon Strategist has substantial experience in regulatory areas required for QMS certification implementation of medical devices, in vitro diagnostic devices, packaging material products, pharmaceuticals products and combination products.
QMS certification service including QMS certification training, layout designs, manufacturing and postmarket support as we have regulatory expertise in auditing, executing and maintaining all features. Our team involves in former U.S. FDA, EU notified body, QMS certification body and Medical Devices Agency professionals with the well built technical expertise to assist and protect your quality systems that can follow with the toughest regulatory inspection.
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The Efforts of Operon Strategist in helping us resolve our various regulatory queries have been outstanding. Their expertise & regulatory knowledge puts them on par with other globally recognized medical device regulatory consultants.
We hired Operon Strategist the medical device consultant as a subject matter expert for overseeing sterilization activity by adhering to the protocol and for reviewing results and reports in line with global standards and our requirements for the commercial launch of a product in the global market. The team exceeded our expectations by providing quality outcome and played a vital role to launch the product in time.