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