Program

Program

Medical Devices

Online course: ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course

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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Online workshop: Regulation (EU) 2017/745 for medical devices (MDR)

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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Online workshop: US regulation 21 CFR 820 for medical devices and registration procedures 510(k)

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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Online workshop: Compliance of medical device software

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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Online workshop: Biocompatibility of medical devices

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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Online workshop: Sterilization of medical devices

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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Online workshop: Requirements of Regulation (EU) 2017/745 for Importers and Distributors of Medical Devices

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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Online workshop: Medical Devices – Guidelines for Preparing a Technical Documentation

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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Online workshop: Requirements of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices - English

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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