QMS · CHANGES

Every change, in one place.

One Change Order, no matter what's changing. Iris drafts the redlines and the impact assessment, you decide. From open to release, connected.

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CO-00045 | Device-A02 EU Market Expansion In Review
ITEMS 3 records affected
Instructions for Use IFU-00012
Translated to 24 EU languages · CE-marked
DOCUMENT
Technical Documentation File TDF-0008
Created per EU MDR Annex II/III
DOCUMENT
MedTech Europe GmbH SUP-00112
EU Authorized Representative · MDR Article 11
SUPPLIER
IRIS · IMPACT ASSESSMENT Drafted from your CO items
Quality
IFU translation verification needed across 24 languages. Training updates for 3 production teams on EU labeling.
Supply Chain
EU Authorized Rep onboarded. Notified Body engagement required for CE marking — not yet initiated.
Regulatory
EUDAMED registration required. PRRC designation needed (MDR Article 15). PMS plan update for EU PMCF.
Manufacturing
EU-specific labeling line setup at manufacturing site. Sterilization validation already EU-aligned.
Accept all → Refine
UNIFIED

One Change Order, no matter what's changing.

Most QMS forces every category of change through its own workflow. When a change spans multiple records, you end up sequencing COs against each other — and sometimes you can't, because of dependency loops. Syneris doesn't have that problem.

NO MORE

No chicken-and-egg sequencing.

When a change spans records of different categories, separate workflows force you into dependency loops. With one CO, the records change together — no juggling COs against each other.

FLAGSHIP

AI-drafted impact assessment.

Iris reads the items in your CO, scans your QMS for connected records, and drafts the cross-functional impact for you to review. Quality, Supply Chain, Regulatory, Manufacturing — covered, with sources.

CONNECTED

Connected to everything.

Suppliers, equipment, training, risk files, SCARs — when any of them are affected, Iris surfaces them. Nothing falls out of scope because somebody forgot to add it.

Bring us your messiest Change Order.

Show us a real change you're working on — across however many records. We'll show you what it looks like running through Syneris, with Iris drafting the impact assessment alongside you.

Book a demo →