Structure, traceability, and accountability for regulated product delivery
Structure, traceability, and accountability for regulated product delivery
Governance for regulated delivery—built around compliance, quality systems, and risk control.
We structure governance so teams can deliver confidently in regulated and audit-driven contexts— with clear controls, evidence, and accountability across the lifecycle.
Our governance model is built on clear structure, regulatory alignment, and continuous control across systems, processes, and delivery.
Alignment with MDR, FDA, IEC 62304, and ISO 13485 to ensure compliant delivery in regulated environments.
Structured QMS frameworks that define responsibilities, controls, and continuous quality improvement.
Proactive identification and mitigation of technical, operational, and cybersecurity risks across systems.
Continuous preparation for internal and external audits through structured evidence, reviews, and gap assessments.
Governance across the full product and process lifecycle-from planning and development to maintenance and change control.
A structured governance cycle that keeps regulated delivery aligned, controlled, and audit-ready.
Identify applicable standards (MDR/FDA, IEC 62304, ISO 13485), system criticality, and key delivery risks.
Define QMS structure, roles, decision points, documentation standards, and quality gates that match the context.
Embed governance into day-to-day delivery through controlled workflows, reviews, and evidence expectations.
Maintain continuous readiness via internal assessments, gap reviews, and traceable evidence packages.
Improve processes and controls based on findings, delivery feedback, and evolving regulatory expectations.
Governance isn’t paperwork-it’s a control system that reduces risk, strengthens delivery quality, and improves decision-making in regulated environments.
Clear alignment to MDR/FDA expectations, supported by structured controls and traceability.
Evidence and documentation organized for smoother audits, reviews, and assessments.
Quality gates and QMS-driven consistency reduce late-stage surprises and rework.
Transparent reporting and decision logs that keep stakeholders aligned and accountable.
Whether you need compliance alignment, QMS support, or audit readiness, we help you build governance that scales with regulated delivery.
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