risk

Integrating Project Risk Management into Medical Devices


Client Issue: “We use ISO 14971 to manage risk in our medical devices, yet we keep missing other risks often causing significant project delays.”

Solution: Risk management, using ISO 14971, is based on user hazards and risks. It does not focus on other forms of risk, including project risk. Project risks cover many different areas of product development. We help you build a robust project risk system in several ways.

  • Risks are restated as assumptions based on the expected state. This helps you understand any gaps in knowledge which could affect your project
  • Assumptions are generated across many different disciplines, including business, development, engineering, operations, etc.
  • Assumptions are generated and evaluated throughout the project. They are an integral part of the project process instead of one time deliverables to each gate or management review.
  • Starting with our s2m Body of Knowledge templates, we work with you to develop a custom template of common assumptions that can be used for your organization.

You may also be interested in our risk based product development process, Exploratory PD, which uses risk resolution to drive the overall development activities.

Post: Beyond the Risk Management File

Post Act Like a Chef When Developing Products

Post: Dealing with Uncertainty in Product Development

NPD-Bytes: Risk Management in Medical Devices

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For more information, contact
Mary Drotar, Partner
Strategy 2 Market, Inc.
[email protected]
312-212-3144
or complete this contact form
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