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

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.

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

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

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

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

Pre-Market Approval (PMA)

The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable predicate exists.

Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices.

De Novo

The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III.

Medical Device Software

A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.

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