ProductUpdated on 27 October 2025
Quality System Support for Medical Devices
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom
About
We help you design, implement, and maintain compliant quality systems aligned to ISO 13485 and 21 CFR Part 820. Our services span:
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QMS setup or remediation
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CAPA & non-conformance handling
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Risk management (ISO 14971)
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Process quality improvement
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Internal/supplier audits
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Complaints & document control
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Training & management reviews
Whether building from scratch or optimising existing systems, we embed quality into your operations from day one — helping you get inspection-ready and stay that way.
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