<html> <body> Kimberly McCoy </body> </html>

Kimberly McCoy

Sr. Director of QMS and RA

As Senior Director of QMS at Eliquent Life Sciences, Kimberly McCoy offers strategic guidance to medical device companies in Regulatory Affairs, Compliance, and Quality. Her extensive experience, spanning over 25 years in the medical device sector, covers a wide range of devices including wound care, orthopedics, SaMD, SiMD, and IVDs/LDTs.

Kimberly's background encompasses product development, RA/QA, clinical affairs, auditing, and training. Notably, she managed the medical device business for a major Notified Body, overseeing over 400 global auditors and technical reviewers with a P&L responsibility exceeding $100 million. Kimberly holds a RAC certification, is a former Chair for the ASQ Medical Device Division, and currently serves as a community member on an IRB. She is fluent in both English and German.

Kimberly at a Glance

Audit Expertise

  • EU MDD/EU MDR
  • EU IVDD/IVDR
  • 21 CFR 820, 803, 806
  • 21 CFR 211
  • ISO 14971
  • ISO 13485
  • ISO 9001
  • MDSAP

QMS Process Expertise

  • PREMARKET
    • Design Controls
    • ISO 62366/Human Factors
    • ISO 10993/Biocompatibility
    • IEC 60601/Electrical Requirements
    • Document Controls
    • ISO 14971/Risk Management
    • Clinical Evaluation
    • Technical Files/Documentation
  • PRODUCTION
    • ISO 14971/Risk Management
    • ISO 19011/Auditing
    • ISO 17025/Calibration and Testing
    • ISO 11135/Sterilization
    • IEC 62304/Software Validation
    • Change Management
    • Process Validation
    • Production and Process Controls
    • Supplier Controls
    • Data Integrity
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Controls
    • Change Management
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA & NB Remediation

Regulatory Submissions

  • USA, Europe and Health Canada
  • 510(k)
  • CE Marking - Technical Documentation

Education

  • BA in Political Science, International Relations, Texas Christian University
  • MBA, University of Phoenix Online

Language

  • English, German

Certifications

  • Black Belt Certification
  • Green Belt Certification
  • Regulatory Affairs Certification (RAC) EU, Regulatory Affairs Professionals Society (RAPS)
  • Regulatory Affairs Certification (RAC) US, Regulatory Affairs Professionals Society (RAPS)
  • ISO 13485 Lead Auditor Certification
  • ISO 9001 Lead Auditor Certification

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Kimberly's Areas of Expertise

  • Regulatory – Has assisted with transition to EU MDR/IVDR compliance for IVD, software, and AI/ML devices. Has managed regulatory submissions to obtain FDA clearance, including IDEs, 510(k)s, and De Novo and technical files for EU MDR and international submissions. As well, has advised companies on maintaining QMS compliance to ISO 13485, ISO 9001, JPAL, FDA QSR, HCT/P, ANVISA, KFDA, and CMDCAS.
  • Quality Management Systems – Has created/implemented QMSs for IVD and medical device companies, as well as improved existing QMSs and implemented quality improvement throughout companies. Also, has developed requirements for content of technical protocols, reports, and summaries used in support of submissions.
  • Auditing – Has performed QMS audits for compliance with FDA regulations, ISO, EU directives, JPAL, ANVISA, Health Canada, and CMDCAS. Also, has interfaced with ISO and FDA audits, providing information, fielding questions, and resolving regulatory and process concerns.
  • Training – Has trained departments/teams to ensure regulatory requirements are implemented/validated (complaint handling, MDR, and regulatory). As well, has educated, trained, and established competency requirements for clients on projects regarding RM techniques, cGMPs, design control, quality systems, product development, and process excellence techniques, focusing on efficacy and efficiency.

Highlighted Experience

As Global Vice President and Head of the Medical Device Division for T?V Rheinland, Kimberly rebuilt relationships with medical device manufacturers, managing customer expectations and setting up new processes and mandatory internal timelines within the Notified Body to streamline and make submissions more efficient. Also reduced approvals timelines for technical documentation and ISO 13485/MDR/IVDR certification.

While in industry, she oversaw RA/QA projects for clients ranging from start-ups to Fortune 100 companies, with 30 to 40 active projects ongoing monthly, including device assessment, classification, label review, contract review, regulatory/quality system implementation, quality analysis (CAPAs, NCs, and remediations) for various device types, such as orthopedic, disposables, cardiovascular, and wound management.

 

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