Welcome To Regulatory Insight
For two decades, Regulatory Insight, world wild medical device consultants, 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
MDSAP Audit Program
FDA 483 Warning Letter
FDA Establishment Registration and Device Listing
U.S. Agent Representation for Medical Devices
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 for Medical Devices
Australian TGA Registration for Medical Devices
Employee Regulatory and Quality Systems Training for Medical Devices
Assistance with Medical Device Import and Export Issues
How We Can Help
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 we have 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
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
Regulatory Insight has designed, managed and analyzed the results of scores of clinical studies for a wide variety of medical devices and IVDs for many different indications and purposes. Regulatory Insight offers the full scope of clinical study services which can be taken as a complete package or from which individual components can be selected, as needed to fit your company’s specific needs.
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.
MEET OUR PRINCIPALS
Kevin Walls, MBA
Principal Regulatory and Quality System Consultant
Kevin has over 30 years of medical device and IVD experience in worldwide regulatory affairs and quality assurance.
Kevin has worked both in the U.S. and abroad obtaining medical device regulatory approval, clearances, registrations and licensing, along with setting up new, and remediating existing quality systems.
Kevin has a B.S. in Electrical Engineering and an M.B.A. and received Regulatory Affairs Certification by the Regulatory Affairs Professional Society (RAPS).
Principal Clinical Consultant
Elvira has over 25 years of experience in clinical trial design, management and outcomes analysis, medical market research and clinical practice.
Elvira has worked both in the U.S. and abroad with leading medical device research organizations and private companies.
Elvira has both a B.S. and M.S. degree in the medical field.