When is CE marking mandatory for medical devices? CE marking is mandatory for all medical devices placed on the EU market that fall within the scope of the Medical Device Regulation (MDR). The marking demonstrates that the device meets safety and performance requirements. The only exceptions are custom-made devices and devices used in clinical investigations. […]
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Here is the English translation: How to Build a QMS System for Medical Devices? A QMS (Quality Management System) is an essential quality system for medical devices that ensures product safety and compliance with regulatory requirements. It includes documented processes, risk management, and continuous improvement methods. A functioning QMS is a prerequisite for CE marking […]
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The frequency of audits in a health technology company is primarily determined by the requirements of the ISO 13485 standard and the MDR/IVDR regulations. Internal audits must be conducted in accordance with the audit plan defined in the quality management system. External audits performed by a notified body are carried out annually. The regularity of audits ensures the functionality and compliance of the quality management system. […]
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European health technology development is undergoing a transition, and new regulatory requirements are challenging companies to find effective solutions. Clinipower is participating in the EU project EU4MEDTECH, which is advancing the development of health technology. EU4MEDTECH Project – Transformation of Medical Technology Evaluation EU4MEDTECH is a 4-year Horizon Europe project that develops the evaluation and […]
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Thursday 26th of May 2022 is a significant day for those operating with in vitro diagnostic (IVD) medical devices in the European Union (EU). This is the date of application of the new EU Regulation 2017/746 on in vitro diagnostic medical devices (IVD Regulation, IVDR), from which the Regulation will be fully applicable, taking into […]
