The Problem

As the company prepared to bring AI-powered digital therapeutics and clinical support tools to market, it faced significant regulatory and quality challenges. There was no formal Quality Management System, no consistent documentation practices, and no standardized processes for software validation, complaint handling, CAPA, training records, or change control.

The absence of these systems posed serious risks:

• Inability to meet FDA, ISO 13485, HIPAA, and SOC 2 requirements

• Operational inconsistency across engineering, clinical, and operations teams

• Increased audit risk and potential delays in product launches

• Gaps in traceability, documentation accuracy, and overall product reliability

To safely scale and enter regulated healthcare markets, the organization needed a robust, compliant, and repeatable quality and regulatory framework, built nearly from scratch.

The Solution

I led the creation and implementation of a comprehensive Quality Management System (QMS) with regulatory compliance framework that aligned engineering, operations, and clinical workflows with recognized healthcare and medical device standards. Key solutions included:

Building the Full QMS Infrastructure

Designed and authored a complete QMS, including:

• Quality policy and manual

• Document and record control procedures

• Internal auditing procedures

• Complaint handling and incident reporting workflows

• Corrective and Preventive Action (CAPA) system

• Training and competency tracking

• Supplier and partner oversight processes

Operationalizing Quality Across Teams

• Implemented standardized templates, forms, and SOPs to ensure consistency and audit readiness.

• Developed training programs and onboarding pathways so employees understood and adhered to QMS requirements.

Regulatory & Compliance Leadership

• Acted as the company’s Privacy and Compliance Officer, taking responsibility for SOC 2 and HIPAA compliance.

• Created audit readiness plans and led evidence collection, policy development, and internal reviews.

• Integrated quality, risk, and regulatory considerations into product development workflows and release planning.

Cross-Functional Integration

• Collaborated with engineering to embed validation, documentation, and traceability into the development lifecycle.

• Partnered with leadership to align QMS processes with business goals and operational scaling plans.

• Established communication channels and reporting structures for ongoing compliance monitoring.

The Outcome

The implementation of the QMS and compliance framework produced significant, measurable, and strategic improvements:

• Established regulatory readiness, enabling the company to pursue medically regulated product pathways without delay.

• Strengthened audit posture, demonstrating clear SOC 2 and HIPAA compliance with a formal audit scheduled for Q1 of 2026.

• Improved product quality and consistency, with standardized validation, documentation, and release processes.

• Enhanced operational efficiency, as teams were trained to follow clear processes rather than ad-hoc, inconsistent practices.

• Lowered organizational risk, through formal risk assessments, CAPAs, and audit cycles.

• Created a scalable foundation, allowing future product lines, clients, and regulated use cases to be supported by the same quality framework.

• Increased stakeholder trust, both internal and external, through transparent reporting, well-documented processes, and dependable quality controls.

Knowledge, Skills, and Abilities

Regulatory & Compliance Knowledge

• FDA software guidance, ISO standards, medical device quality systems

• SOC 2 trust principles and HIPAA privacy/security rule application

Quality Management Expertise

• QMS design, documentation, and implementation

• CAPA management, audit planning, risk assessments, and validation practices

Operational Design & Process Engineering

• Creating scalable, cross-functional workflows

• Establishing policies, SOPs, templates, and governance structures

• Aligning regulatory needs with company goals, enabling both innovation and compliance

Audit Readiness

• Managing timeline-sensitive, cross-team quality initiatives

• Coordinating audit readiness, evidence collection, and leadership reporting

• Training teams, leading compliance discussions, and ensuring adoption of new processes