Christine Scifert

MS, MEM

Partner

 


Christine Scifert

MS, MEM

Partner

Expertise In...

  • Partner with more than 20 years of regulatory experience
  • Senior Director of Regulatory Department for Medtronic Spinal & Biologics
  • Nationally sought-after and highly respected regulatory expert
  • Masters in Engineering Management & Biomedical Engineering
  • Adjunct Professor Regulatory Affairs

Dawn Norman

MS

Partner

 


Dawn Norman

MS

Partner

Expertise In...

  • Partner with more than 20 years of regulatory experience with VC funded start-ups & Fortune 100 device manufacturers
  • Nationally sought-after & highly respected regulatory expert
  • Regulatory strategy & submissions industry expert
  • Quality system 21 CFR 820 & ISO 13485 expert
  • Clinical study design & study execution industry expert
  • Masters in Biomedical Sciences

Ann Dunahoo

Principal Consultant

 


Ann Dunahoo

Principal Consultant

Expertise In...

  • Principal Consultant with nearly
    30 years’ regulatory experience
  • Quality/Regulatory Manager for Medtronic Spinal and Biologics
  • Medical Equipment Validation Protocols (hardware/software)
  • Medical Equipment Field Service Engineer (Abbott Diagnostics)
  • Medical Technologist
    Clinical Immunology
  • ISO 13485 Lead Auditor Certification

Christine Erickson

Principal Regulatory Consultant

 


Christine Erickson

Principal Regulatory Consultant

Expertise In...

Danielle Besal

MS

Principal Consultant

 


Danielle Besal

MS

Principal Consultant

Expertise In...

  • Principal Consultant and expert
    in regulatory affairs management
  • Regularity Affairs Manager at device manufacturers including Medtronic
  • Managed teams in multiple
    classes of trade/submissions
  • Masters in Biomedical Engineering

Heather Neely

RAC, CQA

Principal Regulatory Consultant

 


Heather Neely

RAC, CQA

Principal Regulatory Consultant

Expertise In...

  • More than 20 years of pharmaceutical, biotech, and medical device industry experience
  • Expert in regulatory submissions, audits, project management, microbiology, and equipment validation
  • Regulatory Affairs Certification (RAC)
  • ASQ Certified Quality Auditor (CQA)

Jane Rodd

Principal Consultant

 


Jane Rodd

Principal Consultant

Expertise In...

  • Principal Consultant with nearly 30 years’ quality systems experience
  • Sr. Quality Systems Manager for Medtronic Spinal and Biologics
  • ISO 13485 Lead Auditor Certification

Mary McCombs-Stearnes

BSME, MS

Principal Consultant

 


Mary McCombs-Stearnes

BSME, MS

Principal Consultant

Expertise In...

  • BSME with 25 plus years of design and development engineering experience
  • Director of Engineering with more than 15 years in R&D, Quality and Manufacturing Transfer for Wright Medical and Stryker
  • Experienced in project management, quality and operations engineering support for NPI and sustaining product lines
  • Masters in Industrial Engineering specializing in Engineering Management

Sherry Abel

MS

Principal Consultant

 


Sherry Abel

MS

Principal Consultant

Expertise In...

  • Experience working with small VC medical device companies
  • Domestic and International expertise supporting BLA Class III and PMA Type III devices
  • Over 20 years in Quality and Regulatory FDA industries
  • Master of Science

Heather Hourihan

RAC

Senior Consultant

 


Heather Hourihan

RAC

Senior Consultant

Expertise In...

  • Past experience in support and leadership rolls, including Director of Regulatory Affairs
  • Experienced in product development and manufacturing protocols
  • Regulatory Affairs Certification (RAC)

Maris Garner

RN, CTBS, CQA

Senior Consultant

 


Maris Garner

RN, CTBS, CQA

Senior Consultant

Expertise In...

  • Senior Consultant with 12 Years’
    Experience in Quality Systems Development/Management
  • Compliance Audit Manager for Medtronic Spinal and Biologics
  • Intensive Care Registered Nurse
  • Certified Tissue Bank Specialist (CTBS)
  • Certified Internal Auditor (CQA)
  • ISO 13485 Lead Auditor Certification

Teresa Padilla

Senior Consultant

 


Teresa Padilla

Senior Consultant

Expertise In...

  • Senior Consultant with 25 Years’
    Experience in Quality Systems Management
  • Experience Includes Senior Roles
    at Global Device Manufacturers
  • CAPA Process, Quality Audits, Document Control, Lab Operations
  • ISO 13485 Lead Auditor Certification
  • Six Sigma Engineering Certification
  • Bilingual in English and Spanish

Mahjabeen Waris

MD

Associate Regulatory Consultant

 


Mahjabeen Waris

MD

Associate Regulatory Consultant

Expertise In...

  • Experience and training in both medical practice and clinical research
  • Professional background in Internal Medicine
  • Previously Institutional Review Board Analyst
  • Doctor of Medicine (MD)

David White

MBA

Partner

 


David White

MBA

Partner

Expertise In...

  • More than 25 years’ leadership experience
  • Highly creative, strategic and effective problem solver
  • Expertise includes health services valuation, financial analysis, market research and practice management
  • Works with health systems, rural and community hospitals, specialty service providers, and single and multi-specialty groups nationwide

Drew Hoffman

MHA

Principal

 


Drew Hoffman

MHA

Principal

Expertise In...

  • Leads multidisciplinary teams that address specific client challenges
  • FMV analysis for speaking, consulting, advisory board, education, research and other services performed by HCPs
  • Third-party tier classification methodology for HCPs engaged to provide services to life sciences companies

James Connors, III

MBA, ASA, CFA

Principal

 


James Connors, III

MBA, ASA, CFA

Principal

Expertise In...

  • More than 20 years’ experience in business valuation/financial consulting
  • Expertise includes business and securities valuation to reduce exposure to compliance issues
  • Supports transactions for mergers, acquisitions, and joint ventures in the healthcare industry
  • Extensive expertise across a wide variety of subspecialties, modalities and providers

Carlo Koren

Affiliate Consultant

 


Carlo Koren

Affiliate Consultant

Expertise In...

  • Extensive background in the medical device and biosciences industry
  • Held numerous senior positions in medical marketplace over 25 years
  • Developed and managed The Rake Report orthopedic insider publication
  • Initiated orthopedic ventures that embraced new technologies and introduced international implant device companies to the US