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

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

Human Factors Experts

Our Human Factors Team Expert: Tara Miller

At Sterling Medical Devices, Tara leads our human factors business. She brings over 15 years of experience in clinical studies focused on medical devices and pharmaceutical industries. Tara has overseen the clinical development and clinical research efforts of over 30 partner collaborators at PharmaJet Inc. Before that, Tara worked at Zynex Medical for ten years and helped them grow from a small start-up into a prominent neurostimulation company.

Tara is an Adjunct Professor at Drexel University College of Medicine, Graduate School of Biomedical Sciences and Professional Studies since 2013. Her areas of expertise include pre-clinical study management, human factors evaluations, clinical study design, and operations,  Contract Research Organization (CRO) oversight, regulatory Investigational Device Exemption (IDE) & Premarket Approval
Application (PMA) submissions, FDA negotiations, FDA panel meeting presentations. Tara’s portfolio includes several publications and key professional and personal associations.

Human Factors Services

  • Preparation of robust FDA and EU regulatory submissions
  • Design and testing of device labeling and effective of Instructions for Use
  • Risk assessment support based on postmarket surveillance data and postmarket clinical follow up
  • Support of relevant preclinical validation testing, including conducting formative usability evaluations throughout your project
  • Conducting summative usability validation testing
  • Human factors engineering and usability engineering (HFE/UE) support and testing services to successfully meet the requirements of the FDA and IEC 62366
  • Usability Engineering File planning or audits
  • HFE/UE validation reporting
  • Product risk and liability mitigation analysis of labeling
  • Clinical Evaluation Reports per MEDDEV 2.7.1 Rev. 4 (including but not limited to Adverse Events, Protocol deviations, and endpoint analysis)
  • Good Clinical Practice (GCP) E6 R2
  • FDA Code of Federal Regulations (CFRs)  812, 50, 56, 54, 820
  • Medical Electrical Devices, In Vitro Diagnostics, Biologics, Human Tissue, Vaccines
  • US Clinical Trials
  • CE Marking – Technical Documentation, Risk Management Files, General Safety and Performance Requirements
  • 510(k) Premarket notifications, Premarket Amendments (PMAs), Investigational Device Exemptions (IDEs), US FDA Q-sub, Technical Documentation
  • Clinical trial design and management
  • Drafting study protocols
  • Creating study related documents such as the research plan, IRB submissions, case report forms, recruitment and informed consent documentation
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Resources

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