OUR APPROACH
Three outcomes. One quality system.
We don't measure success by the certificate on the wall or the clearance letter in the file. Success is a device that doesn't hurt anyone, does what the label says, and is on the shelf when a clinician reaches for it.
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SAFETY
No foreseeable harm reaches a patient
Risk management is core to everything we do.
We start from intended use and foreseeable misuse, design controls in before documenting them, and re-evaluate residual risk every time a supplier, material, process or complaint trend changes.
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ISO 14971 risk files, dFMEA / pFMEA
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Design controls and DHF structure
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Complaint handling that feeds the risk file
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Internal audits that test the controls
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EFFICACY
Performs as claimed, every unit, for its whole life
Every claim traces back to a design input and forward to evidence.
Validated processes and statistically sound acceptance activities mean the ten-thousandth unit performs like the first.
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V&V planning and traceability
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ISO 14155 clinical study management
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Process validation (IQ/OQ/PQ) strategy
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FDA and Notified Body technical documentation
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AVAILABILITY
A device that isn't on the shelf helps no one
Design analysis paralysis, supplier issues and change problems take more devices off the market than design flaws do.
This is the pillar most quality systems ignore, and the one where GSD's auditing background matters most.
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Supplier qualification, audits and quality agreements
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DMR development and design transfer
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Change control that protects validated state
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CAPA that fixes root causes; recall readiness
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HOW WE WORK
Right-sized, regulator-agnostic, and run by your people.
Staged to the product
The system grows as the device matures. Design controls and risk management first; production, complaint and surveillance processes when the product actually needs them.
Right-sized to risk
A Class I accessory and an implant should not carry the same documentation burden. We scale the system to the patient risk and the size of your team.
One system, every regulator
ISO 13485 as the core, with QMSR, EU MDR and MDSAP requirements mapped onto it, not three parallel systems your staff has to feed.
Built to be run by your people
We don't leave behind a quality manual nobody uses. We leave behind procedures your team can execute, and the training to do it.
Measured by outcomes
Complaint rates, supplier escapes, first-pass yield, on-time delivery, findings closed. Not how many SOPs were revised this quarter.
Honest
If something in your system won't survive an inspection, we'll tell you before the inspector does.