New Medical Device Regulation - MDRAugust 2021
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.
What is the ISO Standard and How Can You Receive It?January 2021
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.
The Guide for the Beginning Medical Device ImporterMay 2018
You decided to import products that are defined as medical device and from now on you will be called "importer of medical device". Now you must know the Ministry of Health,the customs and the guidelines for import, registration and marketing of medical device. Good luck!
The First Step for ISO 9001 StandardJanuary 2016
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!