COMPLIANCE SOLUTIONS FOR THE MEDICAL DEVICE INDUSTRY

FDA Consulting, LLC specializes in global regulatory strategies, submissions and quality management systems for medical devices and in vitro diagnostics.  Our goal is the client’s success, while maintaining a focus on regulatory and quality compliance.

Modern Work Space
 

WE PROVIDE HIGH-QUALITY INTEGRATED CONSULTING SERVICES
THAT ARE BUILT ON THE FOLLOWING AREAS OF GLOBAL EXPERTISE:

  • FDA Premarket Regulatory Strategy & Submissions

  • Classification, Conformity Assessment Route & Technical Documentation Files for CE Marking

  • Gap Assessments for Conformity With European MDR and IVDR Regulations

  • Design, Implementation, Audit & Maintenance of Medical Device Quality Management Systems (FDA QSR & ISO 13485)

  • Mock FDA Level II QSIT Inspections

  • Regulatory Liaison to Government Authorities & Notified Bodies

  • Labeling & Packaging Compliance

 
 

Timothy Still

“Michael is one of most thorough Regulatory Affairs / Quality Assurance experts that I've worked with over the years. His ability to prioritize issues, develop a regulatory strategy, and successfully implement a tactical plan are exemplary. Michael was responsible for getting our company ready for a FDA visit, and single handily drove the company towards a successful inspection. I would welcome the opportunity to work with Michael again.”

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