REGULATORY CONSULTANCY
(MEDICAL DEVICE)

Regulatory Consultancy (Medical Device)

– Regulatory Gap Analysis

– MDD and IVDD

– MDR and IVDR

– MDD to MDR Transition

– CE Marking

– Technical Document Compilation

– Clinical Evaluation Report (CER)

– Global registrations (Medical Device) and approval

– Change Management Regulatory Support

– US FDA Medical Device Consulting (510(k), PMA etc.)

– Regulatory compliance support

– (All levels – Regulatory Director/Regulatory Manager/Regulatory Associate)