Guide

The regulation and market approval of Drug Device Combination Products (DDCPs) in Europe is a specialized and intricate process due to the combined nature of medicinal and device components. Manufacturers are required to seek a Notified Body Opinion (NBOp), which is a component of the conformity assessment for the EU Medical Device Regulation (MDR)2017/745, when …

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QMS is a set of interconnected elements (Quality Policy, Procedures, Manual, Work Instruction, Records) that directs and controls the organization in consistently meeting customer requirements and enhancing their satisfaction. What is quality management systems? The quality Management System is a framework organizations use to ensure consistency in delivering products, services, and processes that satisfy or …

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Digital technologies are causing a revolutionary change in the healthcare sector. Digital innovations are in the healthcare sector. Digital innovations are transforming the way healthcare is provided, managed, and experienced due to the convergence of medicine and technology. These developments are expediting processes, raising patient happiness, and improving everything from administrative procedures to patient treatment. …

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The Differences Between ISO 9001 and 13485 ISO 13485 is a quality framework tailored for the medical device field, which includes ISO 9001 and additional requirements. Nevertheless, numerous manufacturers of medical devices overlook the significance of evaluating and contrasting ISO 9001 and ISO 13485. By understanding the differences between ISO 9001 and 13485 standards, one …

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FMEA vs ISO 14971 Product safety always remains a priority for any industry, especially those within the manufacturing, healthcare and engineering industries.  FMEA and ISO 14971 are widely recognized methods for assessing and managing risks. The two methodologies provide remarkable frameworks for identifying potential hazards, evaluating threats, and implementing suitable measures to minimize or remove …

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Healthcare is an important service that must have precision and accuracy. But there is always the possibility of mistakes occurring even with the most skilled healthcare professionals. That is where the role of risk management in the healthcare sector comes into play.  Risk management in healthcare refers to identifying, assessing, and mitigating potential threats and …

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