Manage the Risk Management Process to Ensure Successful Product Launches

For more than 20 years, Optimum Technologies has been providing world-class product development services to its clients, with a focus on optics-based medical devices. Now, we can navigate you through the risk management process to insure a successful approval process for your groundbreaking medical devices.

clair strohl risk managerOur Risk Manager, Clair Strohl,
has decades of experience
managing the development of
documentation for submission
of devices for approval in
the US and worldwide markets.

 

Risk Management

Optimum’s Risk Management process encompasses the identification and reduction of product risk, starting at product inception and continuing through launch and beyond for the life of your product. We will:
  • Identify — Uncover, recognize, and describe risks — to initiate the product risk register
  • Analyze — Determine the likelihood and consequence of each risk
  • Evaluate — Rank the risks by determining their magnitude
  • Assess — Assess those risks with the highest magnitudes
  • Plan — Develop a plan to treat or modify those risks to achieve acceptable post-mitigation risk levels
  • Provide — Complete the risk treatment measures for the highest ranking or most serious risks in the Product Risk Register
  • Monitor and Review — Use the Project Risk Register to monitor, track and review risks prior to regulatory submissions.
 
The Process Also Includes:
  • Hazard Analysis
  • Use Scenarios and Environment
  • Use FMEA
  • Design FMEA
  • Process FMEA
  • Product risk register
 
The Bottom Line:
We have the technical expertise and proven process knowledge that helps our clients achieve their fundable milestones — every time.