Mirela Wolford
Principal Quality Assurance and Regulatory Compliance
ASP Health, Inc.
Mrs. Wohlford is responsible for overseeing regulatory strategy, quality assurance, compliance, and Quality Management System activities for ASP Health’s product development and commercialization efforts. During her career, Mrs. Wohlford has supported medtech startups in advancing devices from concept through FDA clearance and commercial readiness, with responsibilities spanning regulatory compliance, supplier management, manufacturing support, and cross-functional project execution.
Professional Experience
- Wohlford Consulting and Services, LLC – Principal Quality Assurance and Regulatory Compliance
- Ontogen Medtech, LLC – Principal Quality Assurance and Regulatory Compliance Specialist
- MetriTrack, Inc. – Director of Operations and Compliance
- RehabTek, LLC – Quality Assurance, Regulatory Affairs, Operations Consultant
- NanoCytomics, LLC – Director of Quality Assurance and Regulatory Compliance
- Northwestern University – Research Associate: Quality Assurance and Regulatory Affairs
- SonoCiné, Inc. – Director of Quality Assurance and Regulatory Affairs
- Vital Systems Corporation – Manufacturing Engineer, Quality Assurance Coordinator
Academic Background
- British Standards Institute, Reston, VA: ISO 9001/ISO 13485:2016 – Quality Management Systems for Medical Devices Certified Auditor
- Regulatory Affairs Professionals Society – Chicago, Illinois, Certification in FDA Effective Medical Device Pre-Submission Interactions
- Center for Devices and Radiological Health (CDRH) – Us Food and Drug Administration (FDA) Silver Spring, Maryland – Certification in Quality System Regulation, Recalls, Establishment Registration and Device Listing
- Expert Rating Solutions, New York: Total Quality Management (TQM) Certification
- “Ion Luca” University – Vocational College (Part of “Moldova” Iasi), Vatra Dornei, Romania, Diploma in Computerized Accounting
- National Center of Informatics – Vocational College, Bucharest, Romania, Diploma in Informatics, Desk Top Publishing