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What is the ISO Standard and How Can You Receive It?
The ISO standard is a quality management standard.What does “quality management” mean? The organization’s conduct.An organization meeting the standard’s requirements is a learning organization, defining for itself the work processes, examining itself and willing to accept criticism in order to advance and improve itself.Read more about What is the ISO Standard and How Can You Receive It?
Registration of Medical Devices: the registration process at the Ministry of Health
Read more about Registration of Medical Devices: the registration process at the Ministry of Health
New Medical Device Regulation - MDR
In about 6 months, the New Medical Device Regulation in Europe will come into force. The regulation is defined as MDR (medical device regulation) and is identified as 2017/745.Read more about New Medical Device Regulation - MDR
Medical Device Regulation (MDR): Person Responsible for Regulatory Compliance (PRRC)
Read more about Medical Device Regulation (MDR): Person Responsible for Regulatory Compliance (PRRC)