“Providing Regulatory Solutions & Quality Systems
                            for the Medical Device Industry"
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"Penny helped our company and me as CEO successfully navigate the Center for Devices and Radiological Health during a very challenging time for our company. Her advice and documentation was instrumental in our ultimate success. One of these submissions was extremely complex, and almost unprecedented with 5 predicates. This particular piece of work has since been recognized by her peers as a watershed accomplishment." 
               R.P. President and CEO
About Us
    We are consistently successful in gaining, we have successfully gained FDA product
    clearances, product CE mark and ISO 13485 certifications for our clients.

We consistently continue to gain FDA product clearances, product CE mark for European entry, and ISO 13485 Quality Management System certification for our clients.  With over 30 years real-world industry experience, we understand the need to balance business growth and regulatory compliance. We are creative but practical in our approach to registration activities and quality management system construction. We are known for hands-on assistance with our clients during their ISO certification by successfully building and implementing a quality management system that is customized for their specific way of doing business. We have successfully guided medical device manufacturers through their premarket application process, and we are most proud of the novel technology devices that we help our clients clear through FDA and bring to market as quickly and smoothly as possible. We are experts at communicating with FDA when the new breakthrough technologies evoke reviewer questions.

 

Awards and Certifications

   

 

Leonard Stauffer Award from Regulatory Affairs Professionals Society (RAPS)
    – Award honors exceptional contributions to mentoring and furthering regulatory professional education
   development, including special achievements related to Regulatory Affairs Certification
     
Fellow, Regulatory Affairs Professionals Society (RAPS) 2009
    – Appointment recognizing the most senior regulatory professionals for their continued significant contributions
   and leadership in the advancement of the regulatory affairs profession
     
Certified Quality Auditor, American Society for Quality (ASQ)
     
RAPS, EU Regulatory Affairs Certification
     
RAPS, US Regulatory Affairs Certification
     
  Mercer University, BS: Management Information Systems
     
A.S. Southern College of Optometry

 

Affiliations

 

Atlanta Chapter Chairperson for Regulatory Affairs Professional Society (RAPS) 2004 to present
     
Board of Directors, Mentoring and Talent Management Committees, Healthcare Women’s Business Association
    (HBA) 2010 to Present
     
Georgia Tech Institutional Review Board, Community Review Member 2009 to present
     
University of Georgia, Education Committee Member: Regulatory Affairs Program 2004 to present
     
Regulatory Affairs Professional (RAPS) active member since 1996
     
American Society for Quality (ASQ) active member since 2004
     
  Association of Clinical Research Professionals (ACRP) active member since 2006
     
  Ophthalmic Women’s League (OWL) active member since 2005

 

Resume

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

          Penny Northcutt
                
 RAC, FRAPS, CQA









  678-428-6978
  penny@pennynorthcutt.com