Cognition

Cognition Corporation is a software company with over 20 years of experience developing SaaS solutions for life sciences product development and regulatory compliance. The company serves MedTech, Biopharma, and combination product organisations, providing structured data management, design control, risk management, and submission-ready documentation tools intended to reduce development risk and accelerate time to market.

Cognition's platform is built around the principle that complex product development data — historically managed through manual processes, spreadsheets, or paper-based systems — requires structured, traceable, and connected data systems to meet regulatory requirements and support efficient submissions. The company positions itself as a partner to medical device and pharmaceutical companies navigating regulatory frameworks including FDA requirements and ISO standards.

Core Products

• Compass® MED — A structured data and design control SaaS solution purpose-built for MedTech. It is designed to help medical device companies manage design controls, maintain traceability, and prepare submission-ready documentation, addressing regulatory requirements such as the FDA's Quality Management System Regulation (QMSR) and alignment with ISO 13485.
• Compass® BIO — A structured content and data management system covering the complete Biopharma product development lifecycle. It focuses on Chemistry, Manufacturing, and Controls (CMC) processes, managing complex datasets and supporting regulatory compliance for drug development.
• Compass® PRO — A holistic risk management solution for combination products, addressing the complexity of managing both drug and device components within a single product development programme.

Key Capabilities

• Structured data management providing traceability across product development workflows
• Design control support aligned with FDA QMSR and ISO 13485 requirements, including integration of risk management, verification, validation, and change control
• CMC process management for Biopharma, including handling of complex datasets throughout the product lifecycle
• Combination product risk management covering both drug and device components
• Out-of-the-box SaaS deployment intended to reduce implementation time and provide a quicker path to regulatory submission readiness
• Support for structured data as a foundation for AI-assisted product development workflows

Industry Focus and Regulatory Context

• Serves MedTech companies navigating medical device regulatory requirements, including the FDA's QMSR effective February 2, 2026, which aligns 21 CFR 820 with ISO 13485
• Supports Biopharma organisations managing drug development data pipelines and regulatory submissions
• Addresses the specific regulatory complexity of combination products, which involve both drug and device regulatory pathways
• Publishes resources including white papers, webinars, and market reports on topics such as design control gaps under QMSR and the role of structured data in AI-driven product development

Leadership and Advisors

• Gerald Wesel serves as Chairman, CEO, and CRO, with a background spanning multiple technology company leadership roles and recognised as an Ernst & Young Entrepreneur of the Year New England Finalist
• David Cronin, Founder and Chief Business Officer for Biopharma, has over 30 years of life sciences industry experience and co-chairs the International Council on Systems Engineering (INCOSE) Healthcare Working Group
• Dale Gallaher, President, has over 25 years of product development experience and previously worked as a product development engineer at General Electric
• David Taylor serves as CTO and VP of Software Development
• The advisory board includes Mike Hess, former Vice President R&D at Medtronic, and consultants with backgrounds in Biopharma CMC and digital innovation
• Spring Lake Equity Partners, represented by Bob Forlenza and Jeff Williams, holds board representation

Cognition Corporation is headquartered in the life sciences software sector and has maintained over two decades of focus on structured product development and regulatory submission solutions for medical device and pharmaceutical companies.