Quality Management System and Regulatory Affairs Consulting

CHRQ Consulting’s goal is to provide regulatory affairs and quality management system consulting services to organizations that are focused on obtaining regulatory market clearance, establishing and maintaining an effective quality management system, and executing successful new product introductions to satisfy their customers and for the increased profitability and productivity for the company.

Chris Hartzog          CH_headshot

  • Medical Device Market Clearance:  US FDA 510(k), Health Canada and Worldwide/International Medical Device Premarket Submissions
  • Quality Management System design, auditing and consulting.  ISO 13485, FDA QSR, ISO 9001
  • Thirty years of experience in electronics/high tech manufacturing and medical device regulated industries
  • Passed certification exams for ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) with experience in medical devices
  • BSI ISO 13485:2016 Lead Auditor Certificate of Competency
  • BSI ISO  9001:2015 Lead Auditor Certificate of Competency
  • Proven track record of managing product releases, regulatory/compliance testing, verification & validation testing, process and quality engineering in high tech, medical device, defense/aerospace, telecommunications and software industries.

Quality Management Systems Compliance:

  • Quality Management System implementation and auditing:  ISO 9001, ISO 13485, 21 CFR 820
  • Quality Leadership
  • Corrective & Preventive Action (CAPA)
  • Design Controls / Product Development
  • Internal Audits
  • FDA / Third-Party Audit Support
  • Hazard Analysis, FMEA, ISO 14971
  • Complaint Handling
  • Personnel Training
  • Verification/Validation
  • UL Factory Inspection Support
  • EMC and electrical safety testing project management

Worldwide Medical Device Regulatory Affairs:

  • US FDA 510(k), Health Canada and Worldwide/International Premarket Submissions
  • CE Marking, Medical Device Directive Assistance
  • Establishment Registration / Device Listings
  • FDA UDI Labeling Compliance
  • Document Authentication/Legalization/Apostilles
  • Notary Public, State of Washington
  • Import-Export:  Import Detentions, Certificates to Foreign Government, ECCN Classification
  • Labeling Review
  • Clinical Study Support:  IDE, ITA, IRB, EC
  • Liaison with Regulatory Agencies
  • FCC equipment registration

Software Tools:

  • Developed Access databases for regulatory approvals, nonconforming material control tracking and purchasing and inventory control.  Experienced with requirements management databases (DOORS Object oriented requirements management), Telelogic defect tracking, Agile PLM system-document control, RELEX reliability analysis, AutoCAD LT, WordPress Content Management System, Microsoft Front Page, Microsoft Project, Microsoft Office applications, Visio, Adobe Acrobat tools, Microsoft Windows, Novell Netware, IBM OS2, Mac OSX, HTML, PHP, CSS

Industry Sector Experience:

  • Medical Device/General IVDs
  • Telecom
  • Commercial
  • Aerospace/Defense
  • Maritime, Mooring, Towing, Rigging

“We are focused on the goals of our clients, sensitive to their business needs, and committed to teamwork.”

CHRQ Consulting, LLC is located in the greater Seattle, Washington area.

Phone:  425.954.6312
Email:    Please fill out the form below to email us.