RESOURCES

Papers

Longer research from Qity on how compliance should be structured, rather than on any single clause. Open access, no form.

PAPER25 pages, open access

A life-cycle approach to AI governance in medical device development

A vendor-neutral life-cycle architecture for an AI management system. At any point, a manufacturer can determine which system is governed, which uses are authorized, which model and data baselines support each use, and which signals reopen a decision.

ISO/IEC 42001ISO 14971IEC 62304ISO 13485

Miguel AzevedoQity

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PAPER21 pages, open access

A systematic approach for the protection of personal data and privacy

A systematic approach to GDPR and ISO/IEC 27701. Accountability held as controlled records and decisions, so a current and defensible account of compliance can be produced without reassembling it from spreadsheets and tickets.

GDPRISO/IEC 27701PIMS

Miguel AzevedoQity

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FREE FROM QITY

COMPLIANCE RADAR

Classify a device, or map what applies to you

Answer structured questions about one product and the Radar returns its regulatory qualification and class across 17 markets, with the rule it relied on, plus whether the software and AI Act provisions bite.

Or map the company instead: which EU and UK cybersecurity, privacy, product safety and AI obligations apply now, and which are coming.

FOUR ROUTES

Device classification~5 min, per market

One minute scan8 to 10 questions

Quick scan~5 min

In-depth mapping15 to 20 min

Open the Compliance Radar qity.app, free, no account

CLEARED!

Take a device to market, one submission at a time

A card game about clearing the FDA. Pick 510(k), De Novo, or PMA, spend effort filing design controls, risk, verification, cybersecurity, and labelling, and hold the boxes against the reviewer before the clock runs out.

Play at qity.cat qity.cat, free, in the browser