When this applies
First. Before any test is commissioned. ISO 10993-1:2025 expects a plan that categorises the device, identifies the endpoints in scope and states the evidence route for each — and reviewers increasingly ask for the plan before they look at the data.
When to run it
At the start of the programme, and again whenever the device, its materials or its manufacturing change. Two weeks of planning at the front is the cheapest thing in this catalog relative to what it prevents.
What you receive
The device categorisation, the endpoints in scope, and for each endpoint the route by which it will be addressed — existing data, chemical characterisation and assessment, or testing. A programme, in other words, rather than a list of tests.
What it does not do
A plan is not evidence. It defines what evidence you need and how you will get it; the testing and assessment still have to happen. It is also not the biological evaluation report — the BER is the document that closes the plan out at the end.
Method
Planning per ISO 10993-1:2025. The device is categorised by contact type and duration, the applicable endpoints are identified, and an evidence route is assigned to each before any testing is commissioned. Turnaround 2 weeks.
Who performs it
This is performed by Groenakker, not subcontracted. The document is issued in Groenakker’s template — or in yours on request at no extra cost — under Groenakker’s ISO 13485:2016 certified quality system.
Usually ordered alongside
No test precedes it — the plan comes first, and it typically removes tests from a list rather than adding them. What follows it is the rest of the documentation set: the biological evaluation report closes the plan out, and a contact-category addition, literature search or change impact assessment extends it when the device changes.
