This tailor-made training is led by experienced trainers and combines theory with reality-based work-shops. The aim of the training is to make you well equipped and prepared to lead the QA/RA function in a medical device organization, to give you the latest information in the field of medical device regulations and quality system standards and provide a great opportunity to network with other colleagues in similar roles. When combined with in-depth training in Quality Management system and Medical Device regulations, such as our advance level training course “Medical Quality Management Systems” you are well prepared for the position as QA-RA Leader, and the role as person responsible for regulatory compliance (PRRC).
After completion of this course you will be prepared to…
The training is suitable for quality and regulatory professionals who want to strengthen their competency in medical device regulation and quality management systems, and need documented competency as “person responsible for regulatory compliance”.
It is also designed to serve as preparation for a personal certification as “QA/RA Leader Medical Devices” (read more about the certification at www.sbq.nu.)
Two years’ experience or more of working with quality and regulatory questions in medical device or pharmaceutical industry. Training/knowledge about QSR and ISO 13485 corresponding to the content of our course “Medical Device Quality Management Systems (QMS)”
 The new EU regulations for medical devices (MDR) and In Vitro Diagnostics (IVDR) requires the manufacturer to appoint a person responsible for regulatory compliance (PRRC) who has specific responsibilities and must show documented evidence of expert knowledge in relevant fields.
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