In Europe, ISO 13485 Standard designated as EN ISO 13485:2016 is seen as the de facto standard for the medical device industry. Get the information you need to design, coordinate and improve your company's QMS as per ISO 13485:2016. ISO 13485:2003 Overview 2016 Purdue Research Foundation About ISO 13485 Based on the broader ISO 9001 standard, ISO 13485 was first implemented in Europe in 1996. Understand and implement a best-practice Quality Management System as per requirements for the medical industry. You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations.įurthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs. Show how it relates to business processes In this course, we will walk through the ISO 13485:2016 standard to: The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device. With this need for implementation, comes a need for understanding of the requirements. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide. ![]() ![]() ![]() ![]() Having a proper QMS in place is essential for medical device-related companies. The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.
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