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 we offer includes testing of the safety and electromagnetic compatibility (EMC) of products, cybersecurity testing, testing according to different harmonised standards, personnel training, interpretation of standards, legislation and certiﬁcation procedures, as well as management system certiﬁcation according to different standards (ISO 13485, ISO 9001, ISO 14001, etc.)and certiﬁcation according to relevant legislation. With these services, we support manufacturers in entering the Slovenian market as well as European and global markets.
The experience we have with the certiﬁcation of medical devices under the current legislation concerning medical devices (Medical Device Directive 93/42/EEC) shows that manufacturers of medical devices who have a good knowledge of legislative requirements, harmonised standards and guidance documents usually complete the medical device certiﬁcation procedure faster.
It is therefore recommended that manufacturers ﬁrst undergo training to familiarise themselves with the requirements of the Regulation (EU) 2017/745 on medical devices (MDR), harmonised standards and the European guidance documents of the Medical Device Coordination Group (MDCG). Information on such training courses, which are available in Slovenian, English, Serbian and Croatian, can be found on the SIQ website under Training – Program – Medical Devices.
In the development phase of a medical device, the manufacturer must involve various experts with speciﬁc skills, such as clinical specialists – doctors who, by examining existing scientiﬁc literature, establish a scientiﬁc medical basis for the development of the device. During the development planning phase, the manufacturer must carry out the ﬁrst risk assessment involving personnel with technical and medical knowledge. At this stage, the manufacturer must also review the general safety and performance requirements (MDR, Annex I) to identify the requirements relevant to the device and production. This enables the manufacturer to determine which tests and veriﬁcations will have to be carried out and which experts will need to be involved – for example, experts in sterilisation, biocompatibility, or electrical safety and electromagnetic compatibility testing. Testing according to the EN 60601 series of standards and other relevant standards can be carried out in our safety and electromagnetic compatibility laboratories. The range of accredited services and other services provided by SIQ laboratories is published on the SIQ website (www.siq.si/en/) under Our Services – Product Testing and Certiﬁcation – About Us.
If the manufacturer performs the ﬁrst testing at the device development stage, any defects will come to light early and can be corrected during the development phase. This saves time and ensures that the device can enter the market sooner.
Experience has shown that medical device manufacturers who are more aware of regulatory requirements, harmonised standards and guidance documents complete the certiﬁcation procedure for their medical device faster.
Find out more about medical device certification and testing.