Guides/Regulatory affairs

Regulatory1:36

Regulatory affairs

What you need for market access: technical documentation, GSPR checklists, declarations of conformity, UDI, EUDAMED and submissions.

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What you need for market access: technical documentation, GSPR checklists, declarations of conformity, UDI, EUDAMED and submissions. Technical documentation, registrations, UDI, declarations and submissions.

What you'll see

1
Regulatory affairs: everything needed to place a device on the market.
2
Technical Documents: the index of your technical documentation.
3
Each document has a version, an owner, an approval status and its file.
4
Essential Requirements: the safety and performance checklist, with evidence.
5
Declarations of Conformity are drafted, signed and versioned here.
6
CE Marking Procedures follow the conformity route step by step.
7
UDI Records hold the device identifiers.
8
EUDAMED and GUDID submissions are tracked by status.
9
Regulatory Submissions and Product Registrations show each market's status.
10
Regulatory Intelligence keeps track of changes in the rules.
11
Inspection Readiness helps you prepare before the auditor arrives.

The screens show sample data for a fictional company, Nordic MedTech Oy. Captions are on screen and available as a CC track.

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