Medical Device Regulatory Affairs Consulting

Services

At Advena USA we understand how complex regulatory compliance requirements can be. Our experts can assist your company with: • Document control solutions • Establishment registration and product listing • FDA 510(k) Pre-market Submissions • EU Technical Files • International product registration dossiers • Preparation and follow-up to FDA inspections • Regulatory compliance training • Responses to recall, deficiency and warning letters • Short-term regulatory staffing • Technical writing and label review We can provide comprehensive, project oriented, regulatory affairs consulting services when you need them most.