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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:

  • QMS setup or remediation

  • CAPA & non-conformance handling

  • Risk management (ISO 14971)

  • Process quality improvement

  • Internal/supplier audits

  • Complaints & document control

  • 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.

Looking for

  • Product
  • Looking for project partners

Organisation

iDE8

Consulting Firm

Inverness, United Kingdom

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