Soumyadipa Banik

As per the draft guidelines laid down by FDA (Food and Drugs Administration), “Remanufacturing” is defined as the process, conditions, refurbishes, replenishing, restoring or any other related act done towards the completion of final device that significantly changes the finished devices performance and conduct or safety specification on intended use. In order to help ensure […]

Global regulatory organizations want evidence that the medical equipment that is manufactured by the medical industry is both effective and safe to use. The expert must be able to demonstrate that the medical equipment satisfies the needs and specifications of the end user. The foundation of design controls depends on various factors of manufacturing of […]

QMS stands for Quality Management System, is an organized system consisting of method and actions that includes Supplier management, Risk management, Designing, Manufacturing, Handling clinical data, Production, Cost Management, Construction, Customer feedback, Dealing with complaints, Distribution, Marketing, Labeling etc. Medical device industry is growing and gaining huge awareness. It is a constructive management system that […]