<html> <body> Candice Betz </body> </html>

Candice Betz

Director, Quality & Regulatory Consulting

Candice Betz has more than 30 years of experience as a quality and regulatory professional for the medical devices, in vitro diagnostic (IVD) devices, LDTs, drug/device combination products, and tissue products. She has an extensive background and a successful track record in operations, regulatory issues, quality systems, and quality improvement. She holds a bachelor’s degree in quality control with a focus in microbiology and science.

As an Oriel STAT A MATRIX consultant, Candice contributes to the development of strategic and operational plans through assessments of regulatory pathways and sound regulatory programs.

Candice at a Glance

Audit Expertise

  • 21 CFR 820,803, 806, 211
  • ISO 13485, 9001

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Control
    • ISO 14971/Risk Management
    • IEC 62366/Human Factors
    • IEC 62304/Software Validation
    • 21 CFR 1040/performance standards for light-emitting products
  • PRODUCTION
    • ISO 14971/Risk Management
    • Process Validation
    • Production and Process Controls
    • Supplier Controls
    • Document Controls
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Controls
    • Document Controls
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA 483 Remediation
    • FDA Warning Letter
    • NB Major Observations

Regulatory Submissions

  • Experience with submissions across multiple device classes in US, Canada, Europe, Japan, and China

Education

  • BS, Quality Control, Kennedy Western University

Training & Certifications

  • ISO 13485 QMS & Lead Auditor
  • EU MDR/IVDR Auditing Certifications
  • MDSAP Internal Auditing 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.

Candice’s Areas of Expertise

  • Regulatory – Extensive cGMP, GLP experience and has assisted with IND and 510(k) submissions as well as the interpretation of regulations for worldwide clearance, approval, and license for Class IIa devices.
  • Quality Management Systems – Experienced in managing quality assurance and quality control teams. Resolved CAPAs and deviations and performed batch record reviews for combination products.
  • Auditing – Directed on-site audits and has performed audits for vendors. Performed complaint reviews and resolved audit findings.
  • Training – Experienced trainer on subjects such as EU MDR (2017/745) and EU IVDR (2017/746) implementation and auditing, as well as Medical Device Single Audit Program (MDSAP) internal auditing.

Highlighted Experience

  • As a Director of QA/QC for one company, Candice directed all aspects of quality assurance and quality control in the cellular therapy industry.
  • Provided regulatory leadership to a company where she directed regulatory affairs activities and managed interactions between that company and healthcare ministries outside of the US.
  • Has managed all aspects of company compliance to regulations and was part of a team that resolved an FDA warning letter.

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