Risk management system for medical devices should be up to date
The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management ISO 14971 for medical devices and steps to implement it during the product development stage.
ISO 14971 an international standard for risk management related to the manufacturing of medical devices. It is recognized by most regulatory authorities as the “de facto” standard for risk management. ISO 14971 is an integral part of an effective quality management system and should be embedded into your medical device manufacturing life-cycle process. A solid risk assessment program helps you identify design issues before distribution, eliminating dangerous problems and the costs associated with recalls.
Medical device companies MUST have established risk management processes that comply with ISO 14971.
And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. Every international regulatory agency you’ve ever heard of accepts ISO 14971, as the risk management standard for the medical device industry. ISO 14971 is a good standard. Informative and descriptive. Easy (enough) to comprehend.
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