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Next Step is a specialized consulting company which provides custom solutions for product development companies in the medical device and diagnostic industry.

Next Step has worked with multi-national teams in Europe and Asia including France, Germany, Italy, Japan, Taiwan, South Korea, Singapore and India.

Next Step operates from the belief that working in collaboration is the most effective method for achieving success. Our approach is to bring our experience, perspective, and learnings along with an extensive network of resources together with the abilities and strengths of the client to identify and deliver successful solutions.

Areas of Service
Product Development: Next Step's experience covers the complete range of product development from voice of the customer to obsolescence management. Specifically next Step has worked with clients to:
  • Assess the client's product development maturity and identify improvements
  • Create product requirements and provide staff training
  • Integrate acquired or licensed design into the client's product development, manufacturing, and support systems.
  • Develop of predictive obsolescence management strategies and sustaining business practices.
  • Assess compliance to global environmental regulations such as WEEE, RoHS, EuP, REACH, and the California Propositions and develop management strategies
  • Project Management: Next Step's experience covers the range from a single project to portfolio management. Specifically next Step has worked with clients to:

  • Assess the client's product development maturity and identify improvements
  • Create a project management office (PMO)
  • Provide the project manager function for design acquisition
  • Provide the project manager function for 21 CFR remediation work
  • Process Improvement: Next Step's experience covers the range from procedural improvements to IT systems. Specifically next Step has worked with clients to:

  • Improve procedures for design control, change control, and CAPA
  • Create processes for obsolescence management
  • Improve processes for order management from entry to fulfillment
  • Optimize manufacturing processes
  • Please contact me to discuss how Next Step can be of service.

     
    Dr. Maret Maxwell PMP
    214-452-1721

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