Pharma and medical devices
Harmonised standards behind every technical file, and transition periods to meet when one is revised.
What we think the standards questions look like
These are hypotheses. We are validating them with practitioners before we write this page in full, and we would rather hear yours than guess.
Harmonised standards behind every technical file
To be confirmed with people who do this work.
Transition periods that start when a standard is revised
To be confirmed with people who do this work.
Documentation and testing that must follow the change
To be confirmed with people who do this work.
What we already know works
Our expertise comes from aerospace, where standards are among the strictest. Knowing which standards apply, noticing when one changes, and turning the change into the right decisions is not an aerospace skill. Every regulated industry needs it. See how we work in aerospace.
Tell us about your standards work
One conversation. We take notes, you get an honest view of whether we can help. If we can, this page gets written from your reality, not ours.
ISO 9001 and ISO/IEC 27001 certification in progress · Rooted in European aerospace standardisation · Operating since 2021 · Office in Berlin
