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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:

  • Software quality audits & strategy

  • IEC 62304 gap analysis and remediation

  • Risk management: DFMEA, cybersecurity, fault tree analysis

  • Software testing strategy: unit, integration, system, UAT

  • Documentation review for submissions and compliance

  • 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.

Looking for

  • Product
  • Looking for project partners

Organisation

iDE8

Consulting Firm

Inverness, United Kingdom

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