Regulatory Insight is a Worldwide Industry Leader in Medical Device Regulatory Compliance, Submission, Training, Export & Import Services
For two decades, Regulatory Insight has provided comprehensive worldwide regulatory medical device consulting services to over 700 global clients in the medical device and IVD industries, ranging from small-scale start-up companies to established Fortune 500 corporations.
Just a sample of what Regulatory Insight can help your company obtain:
FDA PMA Premarket Approval
FDA 510(k) Premarket Clearance
FDA and other Regulatory Body Accepted Clinical Studies
FDA and ISO 13485 Compliant Quality Systems
FDA Establishment Registration and Device Listing
U.S. Agent Representation
Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID)
Medical Device Single Audit Program (MDSAP) Preparation
Health Canada Medical Device and Establishment License
European Commission CE mark
Australian TGA Registration
Employee Regulatory and Quality Systems Training
Assistance with Import and Export Issues
For more information contact Kevin Walls at +1-720-962-5412 or kevin@reginsight.com
Or Elvira Cawthon at+1-615-447-5150 or elvira@reginsight.com
Author: Frederick Sullivan
Hannah Sullivan: As a seasoned journalist, Hannah's blog provides hard-hitting analysis and in-depth reporting on major crime stories. Her thorough coverage and fearless reporting make her a trusted voice in the field.
