Quality at the service of market access
MedicalGroup builds its quality management system according to the requirements of the regulations in force, and has certifications related to its activities: ISO 13485, ISO 17025 for COFRAC tests performed in its laboratories, and compliance with 21 CFR part 820.
The company simplifies market access for its customers, in particular by providing a Masterfile specific to the American market and complete qualification files.
Our expertise in plasma coatings is reflected in a Master File registered in the US, first acknowledged by the FDA in 2009 and regularly updated since.
MedicalGroup has unique expertise:
- Technical mastery, including HA powder manufacturing, coating and packaging of implants
- Customer support, from prototyping to marketing of implants
- New industrial site, new equipment and high capacities
- Professional and committed teams