ProductUpdated on 27 October 2025
Software Quality Engineering for Medical Devices
Managing Director | Principal Consultant at iDE8
inverness, United Kingdom
About
Our software quality services help you meet regulatory, functional, and safety requirements from development to post-market. We offer:
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Software quality audits & strategy
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IEC 62304 gap analysis and remediation
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Risk management: DFMEA, cybersecurity, fault tree analysis
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Software testing strategy: unit, integration, system, UAT
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Documentation review for submissions and compliance
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Project lifecycle management (agile, hybrid, waterfall)
We lead or embed within your team to deliver robust, compliant, and testable software that supports regulatory approval and safe use.
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