PaxMed International

Support with regulatory affairs
Visit Website

Two awards available. Visit the PaxMed website

PaxMed is very pleased to offer up to two hours telephone consultation at no charge to each of two Rosenman 2019 Innovators. We will answer your pressing questions and share an overview of how to navigate the Regulatory Affairs pathway as you develop a medical product that you wish to market in the United States. Our 30+ years of experience, particularly, with the FDA’s dental, orthopedic and restorative device branches, plus our success rate in assisting companies around the globe to clear over 200 510(k)s, make us a valuable resource in clearing your medical device(s). Topics may include the following:

  • Research the FDA web site for previous clearances or Predicates

  • Possible laboratory and clinical testing

  • Pre-submission meetings with FDA

  • Submission of a 510(k) or other premarket dossier to the FDA

  • FDA review process, potential response types, and FDA timelines

  • Discussion about necessary Quality Systems documentation

  • FDA registration & user fees

Even though the list above is impossible to construct and carry through to completion during our consultation time, the candidate(s) will have a sense of the Regulatory Affairs path and the preparation needed to approach the FDA clearance or approval process.

About PaxMed International

PaxMed International is a leader in Regulatory Affairs for the Medical Device Industry. We work with Medical device manufacturers of all sizes, providing the expertise required to rapidly bring to market emerging technical innovations. The PaxMed International consulting team has the qualifications and experience to help bring your device to market. We offer a high-integrity approach to the most daunting challenges for a medical device manufacturer: regulatory product review and regulatory compliance. Working with the PaxMed team means you’re working with experts in regulatory affairs, quality assurance, clinical trials, biocompatibility, biomaterials, and implantable devices.

PaxMed International