DHF Remediation

DHF Remediation DHF Remediation

DHF remediation can have a major impact on your organization. Furthermore, if not completed properly the significant amount of rework that usually has to occur can have a major financial impact to your bottom line. Make sure you get it completed right the first time by letting us lead the way. We have remediated many product files for combination products and medical devices that have passed FDA and CE related inspections.

Deliverables we specialize in:

Design Controls

  • Design and Development Plan
  • User Needs and Stakeholder Needs
  • Design Inputs
  • Design Outputs
  • Design Verification & Design Validation
  • Test Method Validation
  • Trace Matrix

Risk Management

  • Risk Management Plan and Report
  • Design Failure Mode Error Analysis (DFMEA)
  • Process Failure Mode Error Analysis (PFMEA)
  • Use Related Risk Analysis (URRA)
  • Product Hazard Analysis (HA)
  • Risk Analysis Matrix
  • Clinical Risk Benefit Analysis (CRBA)

Design Transfer

  • Creation of Device Master Record (DMR)
  • IQ/OQ/PQ
  • Process Validation
  • Mold Approvals

Available resources specializing in DHF Remediation:

  • Medical Device Engineers
  • Combination Products Engineers
  • Quality Engineers
  • Design Assurance Engineers
  • Design Control Engineers
  • Risk Management Engineers

Ready to get Started?

We provide our clients with DHF Remediation resources though our Consulting, Staffing & Recruitment, and Outsourced Partner Solutions.

Our Clients
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Ready to Talk?

If you like what you see so far, just wait until we start talking. We can't wait to hear about your needs and then implement solutions to take your organization to the next level!

What Our Clients have to say

“Ventura Solutions has been our strategic R&D consulting vendor since July 2017 and has been instrumental in the updating of our risk management quality system as well as authoring risk deliverables for our top projects. His consultants truly became an extended part of our organization as they quickly embraced our company culture, people, and processes to seamlessly integrate onto project teams. They share the same sense of passion to improve physician efficiency and patient satisfaction worldwide. and deliver on commitments with a high level of professionalism and quality. Ventura Solutions is an outstanding resource extension vendor that truly partners with you to exceed your business objectives.”

- Patrick Lee VP R&D Laborie Medical Technologies Corp.

“Ventura Solutions offers consultants with a rare blend of technical expertise + super communication skills. During combination product risk management and design control projects, A Ventura Solutions consultant was assigned as an SME to communicate to clients on very deep technical info as well as put together strategic insights. I would highly recommend Ventura Solutions consulting services for any engineering, quality or similar work.”

- David Amor CEO, Medgineering