Regulatory Affairs Solutions

Navigating the regulatory landscape for medical devices can be quite complex, but it’s crucial for ensuring safety and compliance. Here are some services we provide

Regulatory Strategy and Framework

Country Wise Registrations & File Submissions

• CDSCO India
• US FDA 510K
• Europe CE-MDR
• Americas
• Asia & Asia Pacific
• Africa & Middle East

Device Documentation

Labelling & Artwork Services

Human Factor Engineering