Design Controls

Design Controls Image

Do you need extra resources to implement and manage design controls for your medical device or combination product?

In today’s world of complex medical device products and ever-changing regulatory requirements, specialized design control resources are invaluable to ensure your medical device is in compliance and designed right the first time.

We specialize in design control solutions that satisfy the requirements of ISO 13485 and FDA CFR 21 Part 820.30; we have expertise with the following deliverables:

  • Design and Development Plan
  • User Needs and Stakeholder Needs
  • Design Inputs
  • Design Outputs
  • Design Verification
  • Design Validation
  • Design Reviews
  • Trace Matrix
  • Design Transfer

Available resources specializing in Design Control:

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

Ready to get started?

We provide our clients with Design Control resources through 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