Arab Health - Maven Profcon Services LLP

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Meeting

Agenda of Meeting!

Get the expert advice on regulatory requirements!

CE Certification as per EU MDR or EU IVDR
USFDA 510(k) Approval
Gap Analysis (MDD to MDR, IVDD to IVDR)
NIOSH Certification
UDI Process Implementation

Updation or Preparation of Clinical Evaluation
Updation or Preparation of Risk Management
EUDAMED Registration
Liability Insurance