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Welcome To Regulatory Insight

Regulatory Insight - Helping companies with all medical device issues

Contact Regulatory Insight for all Your FDA Medical Device Compliance
Submission, Training, Export & Import Services

About Us

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: 

 

How Regulatory Insight Can Help

How Can We Help?
FDA Medical Consulting Firms

MEDICAL DEVICE EXPERIENCE

Regulatory Insight has experience with a vast array of medical devices and In Vitro Diagnostics (IVD) devices. To see some of the devices Regulatory Insight has experience with click on the link below

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 

Help with mdecial device submissions
FDA Medical device complicance by Regulatory Insight

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.

Import and export agents for medical devices
Medical device training

Regulatory Insight Can Help Your Company With All Their Medical Device Training Needs From Quality Systems Training to Webinars

Meet The Principal

MEET THE PRINCIPAL

Kevin Walls, MBA

Principal Regulatory and Quality System Consultant 

FDA medial device approval.  FDA approval for medical devices.  FDA medical device compliance

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 +1-720-962-5412 or kevin@reginsight.com

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