GessNet develops digital platforms, governed knowledge services, and expert consulting for regulated medical products. This work is shaped by more than 16 years of experience with safety assurance, risk management, systems engineering, quality systems, and regulatory execution.
Across medical-device, pharmaceutical, and combination-product work, the same pattern appears repeatedly: important knowledge exists but remains divided across functions, documents, suppliers, and systems.
GessNet was created to connect that knowledge, streamline execution, strengthen decision-making, and help organizations build justified confidence across the product lifecycle.
How can an organization keep lifecycle activities, requirements, CQAs, risks, controls, evidence, quality processes, and regulatory submissions connected as the product and organization evolve?
Each stage expanded the scope of the problem GessNet could help the industry solve.
Following FDA CDRH OSEL’s introduction of safety assurance cases for infusion pumps in 2010, GessNet proposed and developed TurboAC in 2011 through close communication with OSEL. Early manufacturer adoption followed, along with FDA- and AAMI-related education and broader risk-management work for medical devices and combination products.
TurboAC expanded into software, cybersecurity, and combination-product applications. QMSpace emerged in 2020 as a broader digital platform connecting design controls, risk management, cybersecurity, safety assurance, Quality by Design, evidence, and lifecycle workflows.
QMSpace launched commercially in 2023. GessNet has continued to expand digital libraries, platform and variant reuse, first-principles safety and effectiveness, expert consulting, and industry partnerships to help organizations streamline connected execution across products and portfolios.
These principles guide product design, consulting delivery, and digital-knowledge services.
Requirements, CQAs, risks, controls, evidence, quality records, and regulatory submissions become more useful when their relationships are visible and maintained.
Digital tools create the most value when they are shaped by practitioners and supported by people who understand regulated implementation.
Confidence in safety and effectiveness should evolve with analysis, evidence, reviews, and decisions, not be assembled only at the end.
GessNet combines digital platforms, expert consulting, and reusable knowledge services to help organizations connect the dots, execute with confidence, and scale proven knowledge across the lifecycle.
Connect with GessNet about your product-development, quality, regulatory, digital, or implementation priorities.
