Organization has to start the plan of certification with management support and the identification of customer requirements for the QMS.
ISO 13485:2016 Lead Auditor Course is a 4 to 5 days training course that allows the professionals to learn the ISO 13485 QMS standard and being capable to utilize it to audit quality management systems of medical devices' suppliers against these requirements.
As ISO 13485 QMS is focused on continual improvement as its main output, organizations can gain improvements in saving time, money, and numerous other resources.
Medical Device Family is defined as per Clause 3.12 as "group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function."

(Continued...)