Quality and regulation Archives - Clinipower Finland Oy

How often should audits be conducted in a health technology company?

Posted on 23.09.2025

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. […]

EU4MEDTECH – Transforming Medical Technology Evaluation

Posted on 19.09.2025

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 […]

CE marking for medical device

Posted on 11.09.2025

CE marking is a critical prerequisite for the successful marketing of medical devices in Europe. This mandatory marking indicates that the product meets all applicable EU regulations and is safe for its intended use. Health technology product development nowadays requires a deep understanding of the CE marking process from the early stages of development work, as considering regulatory requirements later can cause significant delays and costs. The new Medical Device Regulation (MDR) has significantly tightened requirements, and companies need even deeper expertise to navigate successfully in the complex regulatory environment. CE marking (Conformité Européenne) is a statutory compliance marking that indicates a medical device meets all applicable EU directives and regulations. Without CE marking, a medical device may not be placed on the market in the European Economic Area. The marking is the manufacturer’s declaration that the product has been designed and manufactured in accordance with applicable […]

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MDCG 2019-11

Posted on 08.09.2025

The landscape of medical device software regulation has evolved dramatically since the introduction of the Medical Device Regulation (MDR). With software increasingly becoming the backbone of modern healthcare technology, understanding how to properly classify and regulate these digital tools has become essential for manufacturers, developers, and regulatory professionals alike. The MDCG 2019-11 guidance document represents a crucial milestone in this journey, providing much-needed clarity on software classification requirements under the MDR framework. This comprehensive guidance addresses a fundamental question that has challenged the industry: how do we determine when software qualifies as a medical device and what regulatory obligations follow? […] […]

IVD Regulation is coming – are you ready?

Posted on 20.05.2022

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 […]