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

Not sure which rules apply to you

Answer a few questions about your size, sector, and target markets. The Radar returns the EU and UK regulations that apply to you now and the ones that are coming, and names for each one when it starts to bite and what evidence it expects.

Useful before a funding round, a new market, or a first submission, when the question is which obligations you have already crossed into.

A SAMPLE RESULT

NIS2, important entityCyber Resilience ActEU AI Act, high riskGDPR, controller and processorMDR, class IIa

Open the Compliance Radar qity.app, about a minute, 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