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Glossary
With plenty of acronyms, procedures or references, the regulatory and market access
environments are sometimes perceived as daunting. Deciphering the language is the
start to finding one’s path.
A (3) | C (9) | D (2) | E (8) | F (4) | I (8) | M (3) | N (4) | O (1) | P (12) | Q (2) | R (1) | S (6) | T (1) | V (1)

Latest Glossary Articles


Notified Body (NB)

Notified Bodies NB are independent testing laboratories or product certifier companies accredited by EU Member States to perform conformity assessment tasks specified in the Medical Devices Directi

ISO 13485

ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international

Investigational Device Exemption (IDE)

Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a manufacturer can begin a (moderate to high risk) clinical investigation of its medical device in the

Innovation meeting

Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical devices (or using novel manufacturing processes) navig

Pre-Sub meeting

FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in the frame of clinical studies (i.e.

CE-marking technical file

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clini

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