Risk Management – ISO 14971

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Complying with ISO 14971 can be challenging. The ISO 14971 Medical Device Risk Management standard requires you to identify all hazards associated with your Medical Device, estimate and evaluate the associated risks, control the risks, and to monitor the effectiveness of all controls. Risk Management spans throughout the product life cycle from the design phase through the commercialization, production and post-production phases. Risk Management calls for careful planning and appropriate staffing to support the necessary activities.

We have expertise in the application of ISO 14971 risk management for medical devices and combination products, we can ensure you get the following deliverables completed:

  • 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)
  • Risk Management File

Available resources specializing in Risk Management:

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

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We provide our clients with Risk Management resources through our Consulting, Staffing & Recruitment, and Outsourced Partner Solutions.

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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