Training programmes
Our complete solutions in the field of medical devices include expert medical device compliance training programmes – interpretation of standards and regulations.
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.
More about ISO 13485
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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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.
More about testing
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