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 […]
Read More… from How to Build a QMS System for Medical Devices?
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. […]
Read More… from How often should audits be conducted in a health technology company?
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 […]
Read More… from EU4MEDTECH – Transforming Medical Technology Evaluation
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 […]
The image that pops into mind when hearing the term “medical device” often has something to do with physical devices or machines, such as x-ray machines or pacemakers. In addition to these, however, software is an increasingly important part of the medical device spectrum, both as stand-alone devices and as part of other devices. As […]
