Jan 23, 2024 | Regulatory & Compliance
FDA to Harmonise ISO 13485 Standard On December 5 2018, the FDA came forward with its intent to harmonise and modernise the Quality System Regulation (QSR, Title 21, part 820)1 by transitioning to the international standard ISO 13485:2016, which specifies quality...
Jan 8, 2024 | International Business Development
EIC Internationalisation Services by inXso Internationalisation services for EIC beneficiaries in the healthcare sector are provided by inXso in the framework of the EIC Ecosystem Partnerships and Co-Investment Support programme. Due to the extensive network of...
Oct 3, 2023 | Co-Innovation & Development
Background to Clinical Evaluation & Investigation Requirements The Regulation (EU) 2017/7451 of the European Parliament and of the Council of 5 April 2017 on medical devices – came into effect on 26 May 2021, better known as EU MDR 2017/745 –...
Aug 29, 2023 | Regulatory & Compliance
2023 Briefly In recent years, the US Food and Drug Administration (FDA) has faced criticism regarding its review process, the need to keep up with the science today, and updating the regulatory framework accordingly. In response, the year 2023 has been the year that...
