Duane Herberg brings 30+ years of software, systems, and quality assurance experience in the Medical Device industry. 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 for Software as a Medical Device (SaMD) and integrating Software in a Medical Device (SiMD) with electrical, mechanical, and scientific disciplines.
Duane's motto is "Building a Better Foundation for Software”. Great medical device software is built on a foundation of core software practices including Quality Management, Project Management, Configuration Management, Requirements Management, Risk Management, Security, and Development Operations (DevOps).
Duane is dedicated to establishing and continuously improving these core competencies to enable repeatable, cost-effective delivery of high-quality software products.
Duane envisions and builds efficient and compliant quality management systems for international requirements including FDA 21 CFR, IEC 62304, IEC 82304, ISO 13485, ISO 14971, ISO27001, MDCG, MDD, MDR, and IVDR.
Duane's experience and expertise span the entire life cycle of medical device software from premarket submissions to postmarket surveillance, across a variety of software architectures from embedded to cloud computing.
Duane is hands-on with implementation and coaching of leading-edge quality assurance and project management techniques including Agile, Continuous Integration, Continuous Delivery, Continuous Deployment (CI/CD), Risk Management (Project and Product), and Earned Value Analysis.
When Duane is not thinking about medical device process improvement, you might find him trying to engage body as well as mind by dancing with his wife, curling, or just walking the dogs.
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.