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)