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