Welcome To Regulatory Insight
Contact Regulatory Insight for all Your FDA Medical Device Compliance
Submission, Training, Export & Import Services
About Regulatory Insight
For a quarter century 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 510(k) Premarket Notification
-
FDA and ISO 13485 Compliant Quality Systems
-
Medical Device Single Audit Program (MDSAP) Preparation
-
FDA 483 Warning Letter Response and Remediation
-
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
How Regulatory Insight Can Help
MEDICAL DEVICE SUBMISSIONS
Regulatory Insight has extensive experience negotiating the optimal approach to obtaining market approval or clearance for a specific medical device with the U.S. Food and Drug Administration, Health Canada Medical device license, European CE Mark and Australian device approval. Click on the links below to learn more
MEDICAL DEVICE COMPLIANCE
Regulatory Insight prides itself on cost-effectively designing a complete Quality System for your company that is in full compliance with FDA’s Quality System Regulation, as well as the ISO 13485 Standard so that you have only one quality system that meets worldwide requirements. Click on the links below to learn more
US Agent Regulatory Insight has registered many importers of medical devices with the FDA and can register your company with the FDA as an Initial Distributor as well. If your company is based outside the U.S. and your medical devices are being imported into the United States, your company must also be registered with the FDA as a manufacturer, foreign exporter or other type of establishment, as applicable.
Regulatory Insight Can Help Your Company With All Their Medical Device Training Needs From Quality Systems Training to Webinars
MEET THE PRINCIPAL
Kevin Walls, MBA
Principal Regulatory and Quality System Consultant
.jpg)
Kevin has over 35 years of medical device and IVD experience in worldwide regulatory affairs and quality assurance.
Kevin has worked both in the U.S. and abroad with obtaining medical device regulatory approval, clearances, reclassifications, registrations and licensing, along with setting up new, and remediating existing quality systems.
Kevin has a B.S. in Electrical Engineering Technology and an M.B.A. and received Regulatory Affairs Certification by the Regulatory Affairs Professional Society (RAPS).
Kevin also is a Certified Lead MDSAP Auditor and Certified EU MDR Auditor
Kevin can be reached at 720-254-5756 or kevin@reginsight.com