Medical Device Safety Blog

11/12/2026 by GroenakkerSeries: Biocompatibility Test Failures

Cytotoxicity Testing: The Test Most Likely to Fail

Cytotoxicity testing under ISO 10993-5 is the biocompatibility test you are most likely to fail, and its failures are the hardest to interpret. In all the testing we have supported, no test has a penchant for causing headaches quite like it. Here is how the test actually exposes and scores the cells, why its simplicity makes it so sensitive, what a failure does and does not tell you, and the three sampling principles that make any result, pass or fail, one you can trust.

10/28/2026 by Groenakker

Biocompatibility Is an Evaluation, Not a Test (Until Someone Asks for Data)

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 the conditions under which testing can be avoided or minimized, and where the data will still be needed and provides a wealth of information supporting the safety of a device.

5/15/2026 by Groenakker

The Concierge is In

Far from the neglected hotel desk often bypassed for TripAdvisor, Groenakker reimagines “concierge” as its Latin root conservus—a co-servant partnering with clients to navigate the complexities of medical device compliance. With origins tracing from a Roman “fellow servant” to a French “caretaker,” the term reflects our commitment to tailored advisory services and meticulous test subcontracting, ensuring efficiency, risk mitigation, and success. At Groenakker, concierge-level means expertise with skin in the game—delivering not just guidance, but a collaborative journey from concept to market.

Insights & analysis

Cytotoxicity Testing: The Test Most Likely to Fail

Biocompatibility Is an Evaluation, Not a Test (Until Someone Asks for Data)

The Concierge is In