Free worked examples, limited places
We check each supplier change notice for what is missing, draft the evidence request to your supplier, and set out what the change affects and which teams need to act. Your team keeps every decision.
Name one of your suppliers. Within five working days, get a decision-ready case built from a change notice that supplier has published. Nothing from you is needed.
Case preparation for your own authorised review. We do not approve changes or make regulatory determinations.
Changed tubing may already be in stock
No way to tell old from new on receipt
Raw material maker not named
Stated, with no supporting data
No reason given why none is expected
and 3 more gaps, each with the reason it matters
Evidence request drafted: 5 items, ready to send to the supplier
Illustrative example based on a public supplier notice, anonymised. Not a client case.
Enough to identify the change, the parts, the sites and whether a sub-tier supplier is involved.
Enough fact and evidence for your teams to assess it, with no unsupported claims left standing.
Approvals, cut-over and receiving controls in place before changed product arrives.
Your company stays responsible for every change a supplier makes. Yet notices arrive as emails, PDFs and portal forms, often without the facts your teams need. Working out what is missing, what it affects and what evidence to ask for is mostly done by hand.
Delay has a cost. Product waits on hold, quality staff chase the same supplier twice, and sometimes changed material is in stock before anyone has assessed it.
We reviewed what 19 MedTech manufacturers publish about supplier changes. Most ask what is changing and why. Few ask for the facts needed to contain a change.
ask suppliers directly whether a sub-tier supplier is involved.
ask at submission how changed parts will be traced, by lot, date code or serial number.
publish only which changes to notify and when, not what a notice must contain.
From 33 published supplier documents of 19 manufacturers, reviewed October 2026. 11 of them state checkable content requirements for a change notice. The figures describe these published documents, not real notices or the whole industry.
Your documents never leave your company. The worked example uses a notice your supplier has already published. If you want to go further, your team runs the same checklist on its own notices and shares numbers only. The time saved is measured on your notices, not assumed.
Tell us a supplier or part family you buy. We find a change notice that supplier has published. If there is none, we say so.
Within five working days: a decision-ready case checked against a 31-field schema built from 19 manufacturers’ published requirements.
If the example is useful, we send you the checklist with it. Record how long three recent notices took your team, then apply it inside your own systems. Send back the numbers only: gaps by type, hours and follow-up rounds.
Where a change leaves you options (accept and qualify, switch supplier or make a last-time buy), a paid appraisal sets out the cost, time and evidence for each. The work is done inside your own systems. Scope and fee are agreed first.
The free example is a limited validation offer. In return, we ask for honest feedback on whether it would save your team time.
Medical device, IVD and contract manufacturers that receive supplier change notices for materials, components, sterilisation, packaging or manufacturing sites.
Get the evidence brief. Share your own time and cost ranges for three common change types, and receive the anonymised combined results from all reviewers.
Tell us a little about how supplier changes reach you. No confidential detail is needed, now or later. We reply within two working days with the next steps.
Built by a program and governance leader with more than 14 years in MedTech, life sciences software and regulated manufacturing, on both the supplier and manufacturer side.
Your company keeps control of its own:
The aim is to cut the time between a notice arriving and your teams having what they need to decide.
Change Decision Review is a service from HelloPM, based in Ireland.
We support decisions on supplier changes. We do not give legal or regulatory advice, make regulatory determinations or approve changes. Final decisions stay with your team.