Trial Master File briefly explained

Two people sit at a table with open laptops, one pointing at a screen while the other looks on, suggesting a collaborative work session focused on organizing the trial master file.

What is the TMF (Trial Master File) and why is it crucial for studies? Find out why it is considered the “memory” of a study and which regulatory requirements it must meet.

Sample storage briefly explained

A person wearing red and black gloves opens a container of test tubes inside a frosty laboratory freezer, ensuring proper sample storage. Frost covers the surfaces, indicating cold storage conditions.

Why is sample storage critical for sample integrity? Learn how stable temperature ranges, redundant systems, and continuous monitoring ensure reliable results.

ISO 20916 briefly explained

A person holding a pen reviews and marks documents spread out on a desk, including papers with text, graphics, a QR code, and references to ISO 20916. The person's face is not visible.

What does ISO 20916 require for IVD studies? Get an overview of the key requirements this international standard sets out for study organisation.

EUDAMED briefly explained

A brightly lit, modern data center hallway with rows of tall server racks on both sides, featuring glass doors and visible network equipment with glowing indicator lights—perfect for hosting secure eudamed data solutions.

What is behind the EU database for medical devices? A concise summary of modules, current status, and how to use it.

DMIDS briefly explained

Two men sit at a table indoors, discussing dmids documents in front of a laptop. One holds papers while the other has glasses in hand. A woman stands outside in the background, talking on her phone.

What is the DMIDS? Learn more about the BfArM’s platform for device and IVD registration, study submissions and regulatory data exchange.

CRF briefly explained

A woman in a green lab coat and blue gloves types on a laptop at a CRF lab workstation, while another person in similar attire works in the background near laboratory equipment.

How is study data collected and secured? Learn what constitutes a CRF (Case Report Form) and which requirements apply to validation and data protection.

CRO briefly explained

Three CRO scientists wearing white lab coats and safety glasses stand smiling in a bright, modern laboratory, with shelves and equipment visible in the background.

What does a contract research organisation do? Learn more about the role and responsibilities of a CRO – especially for in vitro diagnostics (IVDs).

Notified Bodies briefly explained

Abstract image with a blue background featuring several curved, darker blue stripes sweeping upward from the bottom right, reminiscent of the structured pathways often seen in notified bodies’ processes, creating a dynamic, modern look.

What are Notified Bodies? Learn about their role and responsibilities in the EU market access process for medical devices and IVDs.

Logo of TRIGA-S featuring a stylized yellow and blue square with gray and white curved lines on the left, followed by the text TRIGA-S in bold blue capital letters on a light background.
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