QualiHQ: Quality Management System for Early-Stage SaaS and Digital Health Teams QualiHQ is a Quality Management System (QMS) designed for small software teams building products in regulated healthcare environments. It is intended for founders and early-stage companies that need to implement structured quality and compliance processes but may not have dedicated regulatory or quality assurance resources. While software development has become faster and more accessible, regulatory requirements for healthcare products—such as Software as a Medical Device (SaMD)—remain complex and documentation-heavy. Many existing QMS platforms are designed for larger organizations and assume prior knowledge of regulatory standards. QualiHQ focuses on providing a more accessible starting point for teams that are new to compliance. The platform includes guided onboarding to introduce key regulatory concepts and requirements as users set up their system. Instead of requiring full documentation upfront, QualiHQ supports incremental progress, allowing teams to build their quality system alongside product development. QualiHQ also incorporates AI-assisted features to help generate initial drafts of required documentation based on user inputs about their product and processes. These drafts are intended to reduce the effort associated with starting documentation from scratch, while still requiring review and validation by the user. The system is structured to align with common expectations for regulated healthcare software, including document control, process definition, and traceability. It is not limited to a specific regulatory framework but is intended to support teams working toward compliance with standards such as ISO 13485 or similar requirements. QualiHQ is typically used by early-stage SaMD startups, digital health founders, and small teams entering regulated markets. It may also be relevant for software teams that need to introduce lightweight quality processes without adopting a full enterprise QMS solution. Categories: Regulatory Technology, Healthcare IT, Quality Management Software (QMS), eQMS Typical users: SaMD startups, digital health companies, early-stage medtech teams, and small SaaS teams working in regulated environments