GovernX / Standards / ISO 13485
ISO 13485 readiness & gap assessment
Medical devices quality. Score where you stand, see what is missing ranked by risk, and track every fix to closure, in Google Sheets.
Who it is for: Medical device manufacturers and suppliers preparing for a quality management system audit.
- 44 pre-loaded requirements
- 4 languages
- Instant copy link
- Google Sheets, nothing to install
- English, Français, Español, العربية
- PDF guides in every language
Not sure yet? Try the free ISO 9001 Scorecard.
At a glance
- Standard
- ISO 13485:2016
- Requirements
- 44 pre-loaded, in 5 areas
- Languages
- English, Français, Español, العربية
- Format
- Google Sheets, copied into your own Drive
- Delivery
- Instant, via Gumroad
- Includes
- PDF guides in every language
What you get
- 44 pre-loaded requirements across the quality management system, management responsibility, resource management, product realization and measurement and improvement, including design and development controls, sterile devices, process validation, traceability (UDI), complaint handling, regulatory reporting and corrective action.
- Readiness is tracked by area: Quality Management System, Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement.
- Executive dashboard, assessment engine and automatic gap surfacing.
- 5×5 risk model, CAPA, evidence, documents, training, internal audit and management review.
- Audit-readiness view, pre-audit checklist and a board-ready executive report (Google Doc).
- Four languages: English, Français, Español, العربية, with PDF guides in each.
See it with demo data
The system opens with a fictional company so it makes sense at once. These are the real numbers from the demo sheet.
No documented evidence of design verification and validation.
Owner: Design Engineer · overdue 43 days. One click turns it into a tracked corrective action.
Readiness by area
Weakest area: Measurement, Analysis and Improvement (50%).
How it works
Buy on Gumroad
Secure checkout, instant delivery.
Pick your language
Click your language button on the delivery page.
Make a copy
The system lands in your own Google Drive.
Questions
Is this ISO certification?
No. These are readiness and gap-assessment tools that help you prepare. They do not certify anything, they are not affiliated with or endorsed by ISO or any certification body, and they paraphrase the intent of the requirements without reproducing ISO text.
What do I actually get?
A Google Sheets system you copy into your own Google Drive, in English, French, Spanish and Arabic, plus PDF guides (get started, introduction, process guide, user guide) in each language.
Do I need to install anything?
No. You need a Google account. After purchase you click your language, press "Make a copy", and the full system is yours.
Is my data private?
Yes. Your copy lives in your own Google Drive and the seller has no access to it.