Modules › GSPR Generation

From MDR Annex I to a Word technical file

GSPR Generation

A 32-step sectioned questionnaire turns into a 187-row SPR map; every applicable item is written into the Word document with a justification tied to its regulatory source.

Where
Customer panel
Status
In use
Price
1000 credits
01

Flow

Left to right
01Cover Detailsproduct, code, class, logo
02Sectioned Questions32 steps, Annex I I–II–III
03SPR Map187 rows + device class
04Cell Generationsource-backed justification
05Word + Gapin background, 1000 credits
02

What the generated Word document contains

In the document

  • SPR number and English item heading
  • Official MDR Annex I requirement text
  • Applicable / Not Applicable decision
  • Applied standards, with their year
  • Detailed, source-based justification
  • Technical file section and compliance result

Format and scope

  • Document in English; bilingual print is a separate service
  • Each SPR on a new page, sub-clauses on their own rows
  • MDCG 2021-5 gap analysis table at the end
  • Company logo, name and signature table on the cover
  • A blank line instead of a document code in the justification
  • The document is immutable; re-downloadable on demand

When are credits deducted?

SPR 1-3 are visible without credit; credits are taken only when the Word document is generated — once, 1000 at the start, refunded on failure.

Generation continues in the background while the screen tracks progress. Cells for the same product profile are kept for a week. Re-downloading a stored document costs nothing.

03

Diagram

The whole flow in one image
GSPR Generation — flow diagram
GSPR Generation — flow diagram · scroll sideways →
GSPR Generation — step-by-step animation
GSPR Generation — step-by-step animation · scroll sideways →

Keep your technical file audit-ready.

Every row is produced with its source citation, standard year and technical file section code.

Generate GSPR

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