About us

SIQ enables manufacturers of medical devices to place safe medical devices on the market that comply with the legislation and thus access the European and global market.

Complete solutions

SIQ offers comprehensive range of services in the field of medical devices. In addition to management system certification (ISO 13485,…), we offer certification according to legislation (MDR (EU) 2017/745), testing of the safety and electromagnetic compatibility (EMC), cybersecurity testing, personnel training, interpretation of standards and legislation.

Top professionals and experts

SIQ includes highly trained medical professionals and experts in our compliance procedures.

SIQ services in the field of medical devices

Regulation (EU) 2017/745 on medical devices

SIQ Ljubljana became a Notified body according to Regulation (EU) 2017/745 on Medical Devices on 31 March 2022. On 26 May 2021, the new MDR fully replaced the Medical Device Directive (93/42/EEC) on medical devices.

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ISO 13485 Quality Management System for Medical Devices

By implementing and certifying the quality management system according to the ISO 13485 standard, you will prove to the buyers and users of the medical devices that you meet both their requirements and the requirements of national legislation.

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Directive 93/42/EEC on medical devices

Manufacturers of medical devices may maintain the validity of certificates under MDD 93/42/EEC until 26 May 2024, and by then place devices already certified under the MDD on the market, provided the design and intended purpose of the medical device have not changed significantly.

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ISO 15378 - Primary packaging materials for medicinal products

Primary packaging is an important factor at providing quality, efficient and safe medicinal product.

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Training programmes

Our complete solutions in the field of medical devices include expert medical device compliance training programmes – interpretation of standards and regulations.

Electrical Safety and Electromagnetic Compatibility Testing for Active Medical Devices

In the conformity assessment procedure, the manufacturers of active medical devices must also prove compliance with the essential requirements in the field of electrical safety and electromagnetic compatibility. SIQ is a recognized and accredited testing laboratory for testing and determining product compliance of different types of electrical medical devices and equipment regarding electrical safety and EMC.

 

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