Injunction n ° 2024-DM-047-INJ relating to the establishment of the company Bio Medical Components SAS located in Saint-Blaise-du-Buis (Isère) at 215 route de Bavonne Za Le Talamud

The inspection of Bio Composants Médicales' establishment revealed significant non-conformities and shortcomings. Notified on March 5, 2025, these issues were not resolved satisfactorily through the company's responses between March 21, 2025, and May 14, 2025. The main purpose is to address multiple quality management deficiencies, including documentation, application, and update of the quality system. This impacts the industry by highlighting the need for compliance with medical device regulations, specifically EU directives and MDR 2017/745. Important compliance considerations include defining a quality management system within 8 months, updating change control procedures within 1 month, and implementing supplier management processes within 3 months.