Keep your device on the market and your operations running. We support sustaining engineering, process optimization, supplier transitions, and the everyday work of keeping a commercialized device healthy across its lifecycle.
Most consulting attention goes to getting a device to market. Less goes to keeping it there — but that's where most devices spend most of their lives, and where most of the operational work actually happens.
Sustaining work includes everything from engineering change orders to process re-validations, supplier transitions, manufacturing scale-up, and the ongoing CAPAs that come out of post-market data. It's less visible than a 510(k) clearance, but it's what determines whether a commercialized device remains profitable and compliant year over year.
Novare supports the sustaining phase with the same rigor we bring to development and submissions. Our Principals have been responsible for these programs from inside global medical device manufacturers, and we know what good looks like — and what the recurring failure modes are.
Manage ECOs through design control and change management procedures — including impact assessment and regulatory notification.
Keep Design History Files (Design and Development Files) current as products evolve, ensuring traceability and regulatory readiness.
Update risk management files in response to post-market data, design changes, and emerging hazards.
Plan for and manage component obsolescence — finding replacements, qualifying alternatives, and updating documentation.
Develop manufacturing processes that satisfy design transfer requirements and scale with volume.
Plan and execute installation, operational, and performance qualification of manufacturing processes.
Re-validate processes after equipment changes, facility moves, or process modifications.
Transfer manufacturing between facilities or to contract manufacturers — with documented controls and validation.
Qualify new suppliers, manage transitions, and update supplier quality agreements without disrupting production.
Build and operate supplier quality programs including audits, corrective actions, and ongoing monitoring.
Oversee contract manufacturers including quality agreements, audits, and embedded quality support.
Qualify new components and materials, including testing, documentation, and risk assessment.
Schedule a no-cost consultation. We'll help you scope sustaining engineering, process work, or supplier operations.
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