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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

March 16, 2023

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Regulatory Affairs Experts