ISO 10993 Biocompatibility Testing & Instant Estimates

Biological evaluation & chemistry testing

Your estimate, now. Not in three weeks.

Getting a price for biocompatibility testing usually means emails, a scoping call, and a fortnight of waiting. Here you choose the tests, see turnaround and sample counts on every method, and see your contracted pricing as soon as your account is linked to it, all under one ISO 13485 quality system.

Instant
Pricing for approved
account holders
1 day
Typical account
approval
ISO 10993
Every endpoint
in one catalog
Example program Surface device, >30 days
Cytotoxicity — MEM Elution
2–3 weeks · 1 device
••••
Sensitization — Magnusson-Kligman
8–10 weeks · 6 devices
••••
Irritation — Intracutaneous
7–9 weeks · 2 devices
••••
Program total
Critical path 8–10 weeks
Sign in for pricing
Turnaround and sample counts are open to everyone. Pricing is contracted per client, so it shows once your account is approved.
Included with your account

Plan, size and price a program in one place

Built for our own scientists. The plan builder and the sample-and-timeline calculator come with your account. Once we link it to your contracted price list, pricing appears on every method in the catalog.

Test plan builder
Answer four questions about your device and see which ISO 10993-1:2025 endpoints apply, with the reasoning for each, not just a list.
Build a plan ›
Sample size calculator
How many devices to send for each test, and for the whole program. Cut-and-share pooling means the total is usually less than the sum.
Size your samples ›
Turnaround & method detail
Every method page is open: standard, extraction conditions, scoring, what a pass tells you and what it does not. Planning tools and pricing come with your account.
Browse the catalog ›
Why create an account

It is the unlock, not a toll gate

Pricing is contracted per client, so it cannot be shown publicly. An account is free. We review it and link it to your contracted pricing.

Create your account
Your contracted pricing, instantly
No scoping call, no waiting on an estimate. Price a whole program in minutes.
Save and name estimates
One per device or project. They stay on your account, re-price if anything changes, and go for review when you are ready.
Export for budgets and grants
A document you can put in a budget justification or circulate for approval.
Submit and track programs
Send an estimate request for review. Once we convert it to an order you can follow the work, and reorder from history when the next revision comes.
ISO 13485:2016 certified
Every program we manage runs under Groenakker’s certified quality system, whichever laboratory performs the work.
One standard across the network
Every laboratory is ISO/IEC 17025 accredited and GLP certified to the standard versions FDA recognizes, and has been audited by FDA.
Experts author every assessment
Automation handles the mechanical work; qualified experts author and complete every assessment. Where one requires a board-certified toxicologist, a DABT signs it.

Not sure where to start?

The plan builder shows you which endpoints your device calls for before you spend anything. It comes with your account, which is free.

Test catalog & estimates

Price a program in minutes.

Search by endpoint, method or GRK number and add what your evaluation calls for. Once your account is linked to your contracted pricing, the estimate totals as you go. Turnaround and sample counts come with it.

Not sure what your device needs? See which endpoints may be appropriate for your device →

Start here
Every program starts with a Biological Evaluation Plan.

The BEP sets the endpoint matrix for your device’s contact type and duration under ISO 10993-1:2025, justifies every test you run — and every one you leave out — and is the first document an FDA reviewer or notified body asks for. Testing without one is testing without a defence.

GRK-1001 · ISO 10993-1:20252 weeks to issueAuthored by Groenakker’s biocompatibility experts
Test catalog

Browse by endpoint

Full test catalog →
Cytotoxicity
MEM elution, 1× extract, scored on an L-929 monolayer.
ISO 10993-5
Sensitization
Magnusson-Kligman maximization and in vitro KeratinoSens™ (OECD 442D).
ISO 10993-10
Irritation
Intracutaneous reactivity, plus vaginal irritation with histology where indicated.
ISO 10993-23
Systemic toxicity
Acute injection, material-mediated pyrogenicity, 14 and 28 day repeated dose.
ISO 10993-11
Genotoxicity
Bacterial reverse mutation, chromosomal aberration, mouse lymphoma.
ISO 10993-3
Hemocompatibility
Direct and indirect hemolysis, complement activation, PTT and hematology, or the complete panel.
ISO 10993-4
Implantation
Intramuscular, subcutaneous and bone sites in the rabbit, 2 to 26 weeks.
ISO 10993-6
Chemistry & toxicology
Extractables and leachables with integrated toxicological risk assessment.
ISO 10993-18 / -17
Evaluation plans
Biological evaluation plans and reports that set the matrix before you spend.
ISO 10993-1
Physical & analytical
USP Class VI, particulates, gas pathway VOC and particulates, bacterial endotoxin.
Various
Experts author every assessment
Automation handles the mechanical work; qualified experts author and complete every assessment. Where one requires a board-certified toxicologist, a DABT signs it.
One quality system
Every program runs under Groenakker’s ISO 13485:2016 certified QMS, whichever laboratory performs the work.
Your templates or ours
Reports ship in Groenakker’s format by default — or in your document templates, under your QMS, at no extra cost.

Not sure which tests you need?

The biological evaluation plan sets the matrix. Start there and the rest of the program follows from it.