Basic info
Industry
hospitals and health care
Sectors
Usability Testing
Implement Quality System according to ISO13485 and 21CFR part 820
Outline Regulatory Strategy (FDA
Formulate Design Dossier / Technical File (TF) for Submission
CE) & Manage Regulatory activities
Complement the regulatory process with the appropriate laboratory services
bio testing
Support companies from Zero to Launch
Medical Device
Direct companies in all the development and validation phases
Medical
Establish biocompatibility plans according to ISO 10993 standards
Date founded
2007