Posts in Knowledge Base

The three ISO standards that matter most in life sciences — and what the 2026 ISO 9001 revision means for companies certified today.

Training is a legal obligation under EU GMP and GDP. What the rules require and how to build a training system that survives inspection.

Approval is only the start. How tenders, interchangeability policy and payer evidence decide whether a biosimilar actually gains share.

The EMA no longer expects comparative efficacy studies for well-characterised biosimilars. What the tailored clinical approach means for developers.

New EU pharmacovigilance rules apply from February 2026. Here is what changes for reporting, signal management and inspection readiness.

Two of the hardest questions in medical device compliance today are who takes responsibility, and how the rules apply to software and artificial intelligence. The[…]

The European database on medical devices has moved from “coming soon” to “required now”. Since May 2026, the first EUDAMED modules are mandatory — and[…]

Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database — and getting the[…]

Under the MDR, a device is never “done”. Post-market surveillance turns the CE mark into an ongoing obligation to prove — continuously — that the[…]

For any device above Class I, a notified body stands between you and the CE mark. Understanding how they work — and why capacity is[…]