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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.

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.

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.

ISO 9001 in three steps and your organization is ready for the audit!
We invite you to read this blog to introduce you to the world of quality and pass an external quality audit by an accreditation institute, good luck!