07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
P&L SCIENTIFIC is a professional medical device regulatory compliance and market consultancy company. We mainly engaged in medical devices, in vitro diagnostic reagent products in the international registration, including the U.S. FDA, EU CE, China CFDA etc., and market advisory services.
We assist medical device companies from product design and development process, international registration, market capacity analysis, advisory of the international health regulations, analysis of competition. We have offices both in Miami , the U.S. and Beijing, China , to provide fast local service and communication with the regulatory authorities so as to achieve timelier product registration.
We, as a member of the Regulatory Affairs Professional Society, RAPS, to keep informed of the latest international regulatory requirements. Our existing consultants have either a rich industry experience or a solid theoretical background. Since 2009, we have served numerous clients include a major durable medical equipment manufacturer, medical equipment division of a large healthcare group, and other medical equipment manufacturers.