Scope the program before you spend
The same two tools our scientists use to scope a biological evaluation. Four answers become an endpoint matrix; the matrix becomes sample counts, a timeline and an estimate.
Test plan builder
Four answers. A reasoned first look at your endpoints.
Tell the builder how the device touches the body, for how long and where it will be sold. It maps the device to ISO 10993-1:2025, flags where FDA guidance and EU MDR expect something different, and explains every endpoint it suggests. It is a starting point, not a substitute: every device still needs a biological evaluation plan (BEP), and the matrix you bring gives that BEP a head start.
- Multi-component devices: one contact profile per part
- Market notes for the US, EU, UK, Japan, China and more
- The reasoning behind every endpoint, in plain language
Peripheral IV catheter · circulating blood · 24 h to 30 days · US + EU
- Cytotoxicity
- Sensitization
- Irritation
- Subacute systemic toxicityChemistry route
- Implantation / local effects
- GenotoxicityChemistry route
- Hemocompatibility
- Chemical characterization
- Bacterial endotoxin
Sample size calculator
How many devices to send. Not a guess.
Pick the material form and size, tick the tests, and the calculator sizes every extraction under ISO 10993-12, pools cut-and-share articles across the program and lays the tests out on a timeline. You build samples once and know the critical path before anything ships.
- Extraction ratios and volumes for every test
- Cut-and-share pooling: the total is less than the sum
- Program timeline with the critical path marked
Within 50 miles of Philadelphia? We'll pick your samples up
Size your samplesPeripheral IV catheter · circulating blood · 24 h to 30 days · US + EU
- 55
- devices to send
- 1,782 cm²
- extraction material
- ~23 wk
- program, in parallel
Cut and shared: 55 devices instead of 68 sized test by test
- 1Plan
- 2Sample & timeline
- 3Estimate
Both tools and your contracted pricing come with a Groenakker account. Approval takes one business day and costs nothing.