“Providing Regulatory Solutions & Quality Systems
                            for the Medical Device Industry"
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“REGSolutions specializes in creative regulatory strategies which gain US FDA medical device clearance and approvals. With 30 years in the medical device industry, we have real-world experience and we understand the need to balance business growth and regulatory compliance. Let us help you get your product to market.”
      Let Us Put Over 30 Years Seasoned Regulatory Experience to Work for You

With the changing policies at FDA, it takes a seasoned regulatory professional to understand all the requirements and develop a meaningful and strategic plan to get your products to market. European (EU) clearance has distinct challenges with the new changes to the Medical Device Directive. As such, it takes an experienced regulatory professional to guide your product through the CE marking process.


REGSolutions, LLC provides strategic consulting for medical device regulatory affairs, quality and clinical needs, including registrations for market entry in the USA and European (EU), regulatory rescue, quality system builds, and clinical registrations (IRB, IDE).

We can provide short-term or long-term assistance with:


Quality Management Systems (ISO 13485 and ISO 9001)
USA Medical Device Product Clearances and Approvals (PMA, HDE, Pre-IDE and IDE/IRB, 510k, 513g and DeNovo)
International Submissions
FDA Liaison
Clinical Services
ISO Certification

Our clients include companies of all sizes, from international corporations to local, independent startup firms.


With over 30 years experience in strategic regulatory planning, quality management systems, auditing and training, we have the know-how to get your product to market and keep you in compliance with federal and international regulations.

Let’s talk today about how REGSolutions can help you.

          Penny Northcutt