Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

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
Contact Us
  • This field is for validation purposes and should be left unchanged.

Share this!

Resources

Computer screen of a medical device

September 20, 2021

Ways to Improve Medical Device UX Through Better Design

When it comes to the design and development of medical devices, ensuring a positive user experience (UX) is not a nice-to-have; it’s essential. As users’ needs expand and more connected...
Read More >
View More Blogs
5 Mistakes Medical Device Startups Make

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.
Read More >
View More Videos
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....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis