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Duane Herberg

Duane Herberg brings 30+ years of software, systems, and quality assurance experience in highly regulated industries including Medical Devices, Pharmaceuticals, and Defense. His technical depth, process knowledge, and leadership skills have been key in moving companies from start-up to market leadership positions for technologically advanced products integrating software, electrical, mechanical, and scientific disciplines.


Some of Duane’s recent successes include:

•Software Project Management and Process Improvement to convert a chaotic, fire-fighting, software department to an organization with a strategic structure, well-defined Agile development processes, and achievable project plans.

•Validation of computer systems used in quality management and manufacturing operations, leading to successful restart of a pharmaceutical facility after a voluntary shutdown due to regulatory and quality issues.


A focus on value-added processes and risk-based decision making has enabled Duane to serve as a technical leader and director of quality management processes and product development leading to global regulatory approval and launch of medical device products.


Duane’s demonstrated core competencies include software verification, validation, project management, and implementation of regulatory requirements and quality management systems such as FDA 21 CFR 820.30 (Design Controls), IEC 62304 (Medical device software), FDA 21 CFR 807.87 (510 k), 21 CFR Part 11 (Electronic Records and Signature), GAMP, EU Annex 11, ISO 9001, CMMI, and ISO 13485.


Duane holds degrees in Math and Physics and has attained the following Certifications: is a Project Management Institute: Certified Project Manager (PMP), American Society for Quality: Certified Manager of Quality/ Organizational Excellence; American Society for Quality: Certified Software Quality Engineer; International Software Testing Qualifications Board: Advanced Level Test Manager

When Duane's not thinking about risk management or project estimation, you might find him trying to engage body as well as mind by dancing with his wife, curling in a bonspiel, or just walking the dogs.

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About the Cone


You may be familiar with the Cone of Uncertainty popularized by Steve McConnell of Construx®. 

In addition to the uncertainty surrounding estimates early in a software project, there is also greater risk (more unknowns) - represented here by the red zones. As a project progresses, those risks (should) become less - the yellow zone - and eventually, the project converges toward the goal - the green.


Herberg & Associates is here to help you identify and manage those risks toward a successful outcome for your project.

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