We're at Your Service

QualityHub comprises a top-ranked team of FDA compliance consultants, project managers and medical device regulation experts that know what your company needs in the complex field.

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World-Class Auditing Organization

QualityHub has extensive experience in performing audits for medical device, drug, biologic and combination product manufacturers who operate in a globally regulated environment.

Audits we can perform for your company:
  • Baseline QMS Audit
  • Pre-Approval Inspection
  • Verification Audit
  • Certification Audit
  • Mock FDA Inspection
  • QSIT Audit
  • And more!

Mobilize Expertise and Skill to Deliver Results

Whatever your staffing needs may be, QualityHub can quickly mobilize the right balance of industry expertise and skills to deliver immediate results.

Our temporary staffing program provides interim industry executives, subject matter experts and professionals in the areas of:
  • Quality
  • Research & Development
  • Manufacturing
  • Supply Chain
  • Operations
  • Clinical
  • Regulatory Affairs
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Sharing Our Knowledge for Your Success

QualityHub has subject matter experts with demonstrated excellence in speaking, training and conducting educational workshops. Our passion for learning inspires our trainings and allows us to develop personalized workshops and training experiences that will best fit your company’s culture and environment.

Examples of trainings we provide:
  • FDA Inspection Readiness
  • Quality Management System Training (Good Manufacturing Practices) 
  • EU MDR Requirements
  • Risk Management 
  • Corrective and Preventive Action (CAPA)
  • And many more!

One Size Doesn't Fit All

Whether your company is facing an FDA 483, Warning Letter or Consent Decree, QualityHub can help your leadership team create and execute the plans to overcome your company’s FDA regulatory compliance challenges.

Finding your gaps is just the beginning. QualityHub’s FDA regulatory compliance experts can help you accomplish the work needed to bring your organization into compliance.

We can provide the needed quality system project (strategic) leads, project managers, and subject matter experts who can help guide, coach and move the critical project along.

For more tactical work, our associate consultants can help execute on quality system deliverables and documents. Our interim quality professionals solution can provide interim management and other personnel to ensure the work continues throughout the process of addressing your FDA 483, Warning Letter or Consent Decree.

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Guidance for the Journey Ahead

QualityHub understands the challenges of new product development and obtaining regulatory approvals in a competitive environment where time-to-market matters.

Let us help you with your:
  • Strategic Planning
  • Regulatory Submissions
  • Independent Reviews for Device Design Reviews
  • Design History File (DHF) and Technical File Development
  • Human Factors Engineering

Start With the End in Mind

Effective risk management requires a beginning-to-end approach to establishing, supporting and sustaining device safety throughout the product lifecycle.

Let our team of quality and engineering professionals help you with:
  • Risk Management Program Development
  • Risk Management File Development & Remediation
  • Health Hazard Evaluations (HHE)
  • Post-Market Risk Management Support
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Quality is Not a Cost Center. It's an Investment.

QualityHub will guide you through the development of a clear roadmap to build the foundation for sustainable compliance and continuous improvement.  

  • Development of QMS Compliance/Quality Plans
  • Quality Management System Development, Improvement & Optimization
  • QMS Record Remediation (CAPAs, Complaints, DHFs, RMFs, etc.)
  • Alignment of Quality Management Systems Post Merger/Acquisition
  • Alignment of Drug/Biologic/Medical Device QMS for Combination Products