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Risk management |
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Risk can be defined as a function of hazard severity and the probability that a hazard will occur and as such can be measured. All Medical Device regulations require that a device be safe for its intended use. The assessment of safety involves a “risk benefit analysis”: are the risks involved in using a medical device outweighed by the benefits to the patient?
Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, Qserve’s courses look at the regulatory and reporting requirements of EN ISO 14971, “Medical devices - application of risk management to medical devices”. They are designed to provide an understanding of risk management and risk analysis techniques and methodologies, and to develop the skills required to apply these methodologies appropriate to a particular product. Risk management and analysis is considered throughout the entire life-cycle of the product, in design, production and distribution processes. The relationship between ISO 14971 and ISO 13485 and other regulations is also examined.
Schematic Representation of the Risk Management Process (after ISO 14971)
Qserve, in co-operation with Qserve America, has developed courses for medical device industry professionals which cover all aspects of the risk management of medical devices. Qserve delivers these courses in English or in Dutch, at Qserve offices, external locations and on-site at your own organization, both in the EU and the US. The courses can be concluded, if required, with an examination and/or certificate. For the Benelux, the course marked with an asterisk is provided in co-operation with the NEN, the Dutch Standardization Institute, but given and organized by Qserve. It is normally conducted in Dutch. If preferred, it can be given in English. Qserve offers the following courses:
Course code RM1 Risk management analysis, using (EN) ISO 14971 (2 days with an exam)Course description:This is a two-day intensive course designed to provide participants with a thorough understanding of the impact of ISO 14971 on the decision-making process of medical device manufacturers throughout the life-cycle of their product. It examines various methodologies and strategies for both risk analysis and management. The use of FMEA (Failure Mode and Effects Analysis) or FTA (Fault Tree Analysis) in identifying hazards, their severity and the probability that they might occur, are considered. Control measures and the monitoring of the effectiveness of such controls are discussed. The relationship of ISO 14971 to ISO 13485 in relation to EU/MDD product regulations is considered, as are the requirements of the FDA/QSR. [read more...] Course code RM2 Risk management analysis, using (EN) ISO 14971 (1 day)Course description:This one-day course is designed to provide participants with a broad understanding of the regulatory and reporting requirements of ISO 14971. The basic practice of risk management and risk analysis is considered following the clauses of ISO 14971. Methods for identifying risks, estimating severities and probabilities of occurrence are looked at. Control measures and the monitoring of the effectiveness of such controls are discussed. The relationship of ISO 14971 to ISO 13485 in relation to EU/MDD product regulations is considered, as are the requirements of the FDA/QSR. [read more...] Course code RM3 (Introductory) course/workshop “(EN) ISO 14971 " (half day)Course description: This short (introductory) course is designed for those who require only a rudimentary knowledge of ISO 14971 or as a refresher course for those who are already familiar with its requirements, but not with the latest developments. It can therefore be customized to meet participants needs.
For more information about these courses, please complete the info request form in the "Contact Us" section, quoting the course code. |
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