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Organization Certification

Procedure for Certification of Medical Devices in Accordance with the Regulation (EU) 2017/745 on Medical Devices (MDR)

The path for the entry of a medical device to the market starts with an idea and leads through its production and testing to the eventual certification. It is recommended that the manufacturer contact the notified body already at the development s...

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Complete Solutions for Medical Devices

We provide support to manufacturers of medical devices all the way from the idea and design to the placing of the device on the market with a variety of services – we train, test and certify. The comprehensive range of services...

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Complete solutions for Medical Devices in Accordance with the Medical Device Regulation

Medical devices play a key role in saving lives. They account for more than a quarter of the world market. This is a sector that is constantly and rapidly evolving and that requires constant adaptation of all stakeholders. The human population is ...

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SIQ Ljubljana Becomes a Notified Body in Accordance with the Medical Device Regulation

Following the successful completion of the designation and notification procedure under Regulation (EU) 2017/745 on Medical Devices (MDR), SIQ Ljubljana became a notified body for medical devices on 31 March 2022 and was registered in the

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When an idea gets a drive

20. October 2021 Organization Certification

Management system certification has a long history at SIQ. Everything started thirty years ago when it became clear that it was not sufficient for just one product to pass the testing procedure. All those entering the market should be high...

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