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OUR SERVICES

FDA Regulation Consulting

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What We Do

We help small U.S. businesses achieve, maintain, and optimize operational compliance. We help small businesses drive revolutionary operational change.

Remote Quality Audits <br><span>(aka eAudits; Virtual Audits)</span><

Remote Quality Audits
(aka eAudits; Virtual Audits)

 Design Controls / Risk Management<

Design Controls / Risk Management

 eQMS Document Manage- ment and Change Control<

eQMS Document Manage- ment and Change Control

 510(k) Premarket Notification<

510(k) Premarket Notification

 Costs of Quality<

Costs of Quality

 Training<

Training

Remote Quality Audits

  • Our systematic approach to Planning, Performing, and Documenting REMOTE QUALITY AUDITS results in a Credible, Effective, and Efficient quality audit program
  • Contact Delta Consulting Alliance now for a free consult. You won’t regret it, we promise

Delta Consulting Alliance, LLC

Remote Quality Audits
Remote Quality Audits
Design Controls / Risk Management

Design Controls / Risk Management

  • DESIGN CONTROLS are the foundation for getting your product to market! RISK MANAGEMENT starts in design. Delta Consulting Alliance can help you set the foundation for success
  • Contact Delta Consulting Alliance now for a free consult. You won’t regret it, we promise

Delta Consulting Alliance, LLC

Design Controls / Risk Management

Electronic Quality Management System (eQMS)

  • Every medical device company and ISO company needs an eQMS
  • But you can’t just “plug and play”, the system needs to be configured, and policies, procedures, instructions, and work flows must be established. Training is required
  • We are experts at SYSTEM IMPLEMENTATION
  • Get our HANDS-ON HELP!
  • Contact Delta Consulting Alliance now for a free consult.
  • You won’t regret it, we promise.

Delta Consulting Alliance, LLC

Electronic Quality Management System (eQMS)
Electronic Quality Management System (eQMS)
510(k) Premarket Notification

510(k) Premarket Notification

  • Maybe you have received Emergency Use Authorization for your medical device, but don’t rest on this. Eventually the FDA will withdraw this authorization. Establish proper Design Controls and get that 510(k) out of the way
  • We are experts at design controls and 510(k) submissions
  • Get our HANDS-ON HELP!
  • Contact Delta Consulting Alliance now for a free consult
  • You won’t regret it, we promise

Delta Consulting Alliance, LLC

510(k) Premarket Notification

Cost of Quality

  • Most quality and regulatory professionals do not talk in business terms, by that I mean money ($)
  • Most CEO’s and CFO’s do not consider quality and regulatory functions as a profit center
  • Opportunities for cost reduction and cost avoidance are
  • Get our HANDS-ON HELP!
  • Contact Delta Consulting Alliance now for a free consult
  • You won’t regret it, we promise

Delta Consulting Alliance, LLC

Cost of Quality
Cost of Quality
Training

Training

  • ISO 13485 Quality Management Lead Auditor Training
  • Complaint Handling Overview
  • Complaint Handling Detailed
  • cGMP for Executives
  • cGMP Detailed
  • Corrective and Preventive Action Overview
  • Corrective and Preventive Action Detailed
  • Cybersecurity Overview
  • And more. Contact Delta Consulting Alliance

Delta Consulting Alliance, LLC

Training