Regulatory Affairs Experts

Our Regulatory Team Expert: Carrie Hetrick

At Sterling Medical Devices, Carrie leads our regulatory, clinical, and compliance business. Carrie represents clients to both local and global regulatory agencies and routinely functions as an on-demand head of regulatory, clinical, or development to companies ranging from small, virtual companies in early development through sizable medical product companies with commercial assets. Her extensive international experience has helped companies navigate regulatory, clinical, and operational challenges facing each stage of development. Carrie has coordinated and complied over 90 complex regulatory submissions with her proficiency in leading early and late-stage cross-functional medical product development programs. Find some of her core competencies below!

Regulatory and Clinical Specific Submission Support

  • US: Pre-Market Authorization (510(k) application process support), 513(g) support, Requests for Determinations (RFDs), Premarket Approval (PMA), De Novo Petition, Investigational Device Exemption (IDE), Investigational Review Board (IRB), Emergency Use Authorizations, Local Agent Services, UDI Services, NIOSH applications
  • Europe: Technical File Preparation & Submission, CE Marking and Approvals, CER/PER Writing & Updating, EU MDR/IVDR Consulting & Gap Analysis.
  • Emerging Countries: Country-Specific Submissions
  • Clinical protocol and study development

Global Regulatory Consulting

  • Worldwide regulatory strategy, compliance, and support
  • Interpretations of local requirements including Medical Device Classifications, licensing, registrations and renewals.
  • US FDA regulatory submissions (510(k), PMA, De Novo, IDE, 513(g), etc.)
  • Experienced with successful transitions and implementation of multinational companies to the EU MDR and IVDR
  • EU MDR and IVRD Technical Documentation
  • EU MDR Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), Post Marketing Clinical Follow up Plans (PMCF), PMCF Reports, Periodic Safety Update Reports (PSUR), and Post Marketing Safety Reports (PMSR)
  • EU MDR/IVDR transition process, procedures, and tools

Other Services

  • Global Product Design and Regulatory Compliance Services
  • MDSAP Regulatory Compliance
  • Post Market Support, Surveillance, and Remediation
  • Post Market Clinical Follow-up
  • Remote Support
  • Quality Systems Implementation, MDSAP, and Remediation
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Resources

July 28, 2015

Is Your Medical Device an Entry Point for a Cyber Attack?

The Internet of Things (Iot), the continual proliferation of mobile medical devices, and the growing amount of data in hospital systems are trends medical device manufacturers should closely follow....
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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