New technology enables new effective diagnostic and therapeutic methods as well as new challenges in controlling new hazards. Manufacturers of medical devices are expected to comply with a more demanding regulatory environment as effectively reducing risks, as low as possible for patients and bystanders. It is essential to establish processes that are aligned with the state of the art related to technologies used as well as an effective state of the art risk management process.
This webinar provides guidance on how to implement the requirements of EN ISO 14971:2019 in your quality management system and how to deal with critical elements of the quality management system.
During the course you will also get a thorough understanding of the major changes in the newly updated EN ISO 14971:2019, as compared to the 2012 version as well its relation to the new Medical Device regulations (MDR/IVDR)
Participants will get to know the key elements of a risk management system in line with the requirements in EN ISO 14971:2019 and MDR. Completion of this course will give you the knowledge needed to assess and update your current risk management process
The course is suitable for persons working with R&D, production, process development or QA who is involved in, or responsible for the operation or audit of a Risk Management System for medical devices who need to know the changes introduced in ISO14971:2019 (EN ISO 14971:2019).
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