Feb 12, 2024 | Case Study
Case Study Clinical Evaluation & Investigation of Active Therapeutic Device Project OverviewAn EU-based deep medical technology startup sought to bring its first medical innovation to the EU market. The breakthrough technology, which originated from a university...
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...