Insignia Medical Systems

A fresh look at an existing ISO 13485 QMS to realign with the business

Client Challenge

Insignia Medical Systems builds PACS software for medical imaging and storage, serving private healthcare providers and NHS trusts.
Years of over-reliance on a previous consultant had left them with a QMS built for someone else’s business, so we were brought in to reclaim ownership for Insignia and make the system theirs again.
A fresh look at an existing ISO 13485 QMS to realign with the business.

“Alistair has helped us enormously and given us the confidence to simplify and modernise our QMS processes for good, after a first phase that already felt cathartic.”

Key challenges included:

Legacy QMS full of irrelevant, inherited material

No consultant relationship after years of reliance

Leadership disengaged from their own processes

System needing simplification, not just updating

Ownership needing to return to Insignia itself

Outcomes achieved

Bespoke QMS fully digitised and business-aligned

Leadership team back in ownership of their processes

QMS now describes real ways of working

Confidence to develop the system further, unaided

Legacy irrelevant material stripped out entirely

Gosh, you shouldn’t have…

Kind words from our clients

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