Jackie Torfin | CEO of QLeaR Advisors

Quality, Leadership, Regulatory Advisors

QLeaR Advisors specializes in providing Quality & Regulatory Compliance consulting to the Medical Device & Pharmaceutical industries. Their team of experts provide creative and efficient solutions to support teams in meeting regulatory hurdles with a cost-conscious approach in mind. 

QLeaR Advisors is committed to enabling Quality teams to be successful, by providing the following services: 
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  • QMS Design & Implementation
  • Regulatory Strategy & Submission Support
  • FDA Inspection, Readiness & Remediation
  • QMS Software Implementation
  • QMS Change Management
  • GCP, GMP, & GLP auditing

Hammerhead CyberDefense

Milada Copeland & Natasha Overbo

Hammerhead's security experts have a combined 40+ years of experience in cybersecurity, risk management, military leadership and operations, finance and medical device security and quality assessments. 

Specifically, Hammerhead assists businesses developing new medical devices with the following primary services: 
  • Cybersecurity Risk Management
    • Thorough ​Risk Assessment
    • Cybersecurity Controls
    • Cybersecurity Management Plan
Additional services include: 
  • SOUP Assessment
  • SBOM Review
  • Fuzz Testing, Penetration Testing, Fuzz Testing
  • Vulnerability Chaining
  • Cybersecurity Documentation for FDA Submission
  • Threat Modeling