ISO 13485:2016 requirements on-demand eLearning (TPECS) >
Designed to increase your knowledge on the requirements of ISO 13485:2016 Quality Management System Standard, key principles and interaction with ISO 9001:2015.
ISO 13485 represents the medical device industry's quality management system (QMS) standard. It specifies requirements for an organisation to design and implement a quality management system able to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Obtaining an ISO 13485 Certification with BSI ensures worldwide recognition for your organization compliance with ISO 13485 requirements. It also represents solid starting point if you are thinking of applying for MDR and IVDR.