Biological evaluation & chemistry testing
Concierge-level advisory and test subcontracting for medical device manufacturers, at industry-leading turnaround times, under an ISO 13485:2016 certified quality system.
What we do
Every program starts with a rigorous biological evaluation, so you test only what the evidence requires. From there we manage the chemistry, the testing and the sterilization through to a file ready for your submission.
All servicesPlan and report your device’s biological safety, and test only what the evidence requires.
Chemical characterization and toxicological risk assessment in one integrated study.
We select the lab, manage the protocols and review every result.
Cycle development and validation for EO, radiation, steam and low-temperature methods.
Planning tools
The same tools our scientists use to scope a program. Four answers become an endpoint matrix; the matrix becomes sample counts, a timeline and an estimate.
Test plan builder
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.
Peripheral IV catheter · circulating blood · 24 h to 30 days · US + EU
Sample size calculator
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.
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
Cut and shared: 55 devices instead of 68 sized test by test
Both tools and your contracted pricing come with a Groenakker account. Approval takes one business day and costs nothing.
Pricing comes first, not last. One owner from the evaluation plan to the final report, and nothing runs until the scope has been reviewed with you.
Phase I
Plan
01 – Contact type, duration and target markets set the endpoint matrix, in the plan builder or on a call.
02 – A biological evaluation plan states what existing data already answers, so you test only what the evidence requires.
Phase II
Price
03 – Add methods to an estimate. Turnaround and sample counts are on every method page.
04 – Your contracted pricing appears once your account is linked. Submit the estimate for review.
Phase III
Test
05 – A scientist confirms the scope with you and the estimate becomes an order.
06 – Protocols are issued and the work is scheduled across the laboratory network, tracked against the critical path.
Phase IV
Deliver
07 – Reports are reviewed by our scientists and issued under Groenakker cover, ready for your technical file.
08 – Adoptions, requalification and change assessments keep the file current between submissions.
Every program we manage runs under Groenakker’s certified quality management system, whichever laboratory performs the work. Advisory and test subcontracting meet the highest medical device standards, with precision and attention to detail on every file.
From biocompatibility to toxicology and sterilization, that is what lets us deliver reliable, high-quality, submission-ready evidence that accelerates your path to market.
How we workEvery program includes
Insights
ISO 10993-1:2025 frames biocompatibility as an evaluation, not a testing exercise — yet in roughly nine of every ten programs we see, FDA or a Notified Body still wants test data. A well-built Biological Evaluation Plan establishes how close a device sits to…
Read the articleFar from the neglected hotel desk often bypassed for TripAdvisor, Groenakker reimagines “concierge” as its Latin root conservus—a co-servant partnering with…
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