The course will present the requirements of the standard EN ISO 13485:2016 for the quality management system in the production of medical devices (and related services) and related legislation applicable to the field of medical devices.
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Medical devices placed on the market must comply with the Regulation (EU) 2017/745, which applies to each individual product of a particular type or model and it has in certain areas has a significant impact on the QMS, the devices themselves, the manufacturers, the importers and the distributors of medical devices.
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Regulatory requirements for medical devices on American, European or other global markets differ. Prior a successful sale on US market the medical device shall be registered (e.g. procedure acc. 510(k)), as well as quality system regulation principles acc. 21 CFR 820 shall be respected by medical device manufacturer.
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In order to prove the conformity of a programmable active medical device according to medical directives, it is necessary to provide compliant software, which must be safe and effective.
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Biocompatibility of medical devices is an important characteristic of safe and compliant medical devices. The main steps for ensuring biocompatibility are specified in ISO 10993-1 standard.
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Sterilization is one of the key processes in the production of sterile medical devices. Among the different sterilization types, each has its advantages and disadvantages. Evidence of successful sterilization is important and expected when demonstrating conformity with regulatory requirements.
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Regulation (EU) 2017/745 on medical devices (MDR) also sets out obligations for economic operators such as importers and distributors. The new commitments emphasize the importance of the responsibility of economic operators for medical devices in a certain part of the life cycle, such as storage and transport. At the workshop, we will talk about the practical fulfilment of the requirements of MDR 2017/745 for importers and distributors.
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Regulation (EU) 2017/745 on Medical Devices (MDR) also deals with the preparation of a technical documentation to demonstrate conformity of a medical device. Changes relate mainly to the manner and complexity of presenting evidence of compliance of a medical device. A technical documentation has gained in importance in the process of demonstrating compliance, and its preparation is of focal importance. The content and complexity are determined by various factors, especially the classification, intended use, type of a device, specific properties of the product, method of production, etc.
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IVD medical devices are tests used on biological samples (such as tissue, blood, or urine) to determine a person’s health. There is a very wide range of IVD medical devices, from pregnancy self-testing aids, blood glucose meters to HIV tests, blood group tests and various types of cancer tests. Unlike medical devices or IVD pharmaceuticals, medical devices never come into contact with a person and do not treat patients but provide information about the functioning of the body. IVD medical devices do not cause direct harm, but they pose a very high risk if their use leads to misdiagnosis. A detailed definition of IVD medical devices is given in Regulation (EU) 2017/746, Article 2.
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SIQ offers a comprehensive range of services in the field of medical devices and also acts as a Notified body for certification according to Regulation MDR (EU) 2017/745, as well as an accredited certification body for various quality management systems (ISO 13485, ISO 15378,…).
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SIQ Ljubljana is a trusted and independent third-party institute, providing complete testing, assessment, certification, and inspection services. We enable our partners to gain trust and receive tailored services, and global market acceptance of their products. Our experienced staff can test your product at any stage of development, from the early design phase to the final product.
We are looking forward to hearing from you and will be happy to get in touch to discuss further details.
