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

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

Expertise In...

• Principal Consultant with nearly 30 years of 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

MS, M.Ed.

Principal Regulatory Consultant

Expertise In...

• 18+ years of medical device industry experience within quality assurance and regulatory affairs
• Master in Regulatory Science
• Master in Education (Learning Technologies)
• Experience with FDA and international regulatory agency requirements and standards; medical device (PMA, HDE), devices and/or combination drug-device

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

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

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

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

Principal Consultant

Expertise In...

• 12 years of 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

Expertise In...

• Senior Consultant with 25 years of 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

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

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

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

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

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