Medical regulatory affairs and quality management systems require specialized knowledge and skills that many companies don’t have.  If you are an entrepreneur, your growth can exceed your ability to add resources.  But don’t worry:

We are here to help!

CHRQ Consulting can help you:

• Register your establishment with FDA
• National Drug Code (NDC) submissions for OTC drug products
• Get your medical devices cleared and listed with FDA
• Provide regulatory strategy and guidance
• Quality management system design, implementation and maintenance
• Internal Auditing to ISO 13485, ISO 9001, FDA 21 CFR 820
• Post-market surveillance assistance

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.

Christopher Hartzog          

• Medical Device Market Clearance:  US FDA 510(k), De Novo, Health Canada and CE Marking….Worldwide/International Medical Device Premarket Submissions
• Quality Management System design, auditing and consulting.  ISO 13485, FDA QSR, ISO 9001
• Over 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
• Medical Device Single Audit Program (MDSAP) Trained
• 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.
• Extensive experience in medical diagnostic ultrasound imaging and high intensity focused ultrasound

Worldwide Medical Device Regulatory Affairs:

• US FDA 510(k), Health Canada and Worldwide/International Premarket Submissions
• CE Marking, Europe Medical Device Regulation (MDR) Assistance
• Device/Drug Establishment Registration and Listing
• 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

Quality Management Systems Compliance:

• Quality Management System implementation and auditing:  ISO 9001, ISO 13485, FDA Quality System Regulation 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

Industry Sector Experience:

• Medical Devices
• General IVDs
• OTC Drug Products
• 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.