Regulatory Insight, Inc.

Sobre Regulatory Insight, Inc.

We have provided comprehensive worldwide regulatory medical device consulting services to over 700 global clients in the medical device and IVD industries for a quarter century, ranging from small-scale start-up companies to established Fortune 500 corporations. The company assists with obtaining FDA 510(k) Premarket Notification, FDA PMA Premarket Approval Application, FDA De Novo Reclassification Request, FDA and ISO 13485 Compliant Quality Systems, Medical Device Single Audit Program (MDSAP) Preparation, FDA 483 Warning Letter Response and Remediation, FDA Establishment Registration and Device Listing, U.S. Agent Representation for Medical Devices, Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID), Health Canada Medical Device License (MDL) and Medical Device Establishment License (MDEL), European Medical Device Regulation (MDR) CE mark, Australian TGA Registration for Medical Devices, Employee Regulatory and Quality Systems Training for Medical Devices, and Assistance with Medical Device Import and Export Issues.

Por que Escolher Regulatory Insight, Inc.?

Atualizações Recentes

Medical Device Submissions

Medical Device Compliance

Imports/Exports/US Agent

Medical Device Training

Additional Services