Alignity IQ guides medical device and life-science innovators through FDA, COFEPRIS and global regulation — and builds the AI that makes compliance continuous.
End-to-end regulatory strategy for medical devices and life sciences: FDA and COFEPRIS registrations, SaMD pathways, R&D product support, and specialized training.
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Our artificial-intelligence platform for continuous compliance in manufacturing: regulatory monitoring, automated audit readiness, and risk intelligence across every project.
Discover the platform →We help manufacturers and innovators navigate the world's most demanding regulatory frameworks — with the precision of specialists and the perspective of strategists.
Classification, technical documentation, quality systems (ISO 13485, 21 CFR 820) and full lifecycle regulatory support for Class I–III devices.
510(k), De Novo, PMA strategy and submissions. Establishment registration, device listing, and FDA correspondence management.
Sanitary registrations, renewals and modifications for Mexico. Local representation and regulatory liaison with COFEPRIS.
Regulatory pathways for software-driven devices: IEC 62304, cybersecurity documentation, AI/ML change protocols and clinical evaluation.
Regulatory input from the earliest design stages — usability, risk management (ISO 14971), pre-submissions and testing strategy.
EU MDR, UKCA, Health Canada and LATAM expansion strategies coordinated from a single regulatory roadmap.
Plant design and construction, manufacturing site changes, process condition changes, and full documentation build-outs — managed so a facility change never stalls your regulatory timeline.
Preclinical and IND-enabling documentation support for early-stage programs, coordinated with hands-on GMP manufacturing and testing capacity.
Our consultants have guided submissions across the FDA, COFEPRIS and EU frameworks for devices ranging from surgical instruments to AI-powered diagnostics.
Alliances with organizations that share our commitment to regulatory excellence and technical rigor.
Design & construction of biotechnology manufacturing plants. Led by Oscar Morales.
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GMP-ready CDMO · Cleanroom manufacturing for early-stage biotech & cell therapy.
Visit site →Practical, expert-led courses for regulatory, quality and R&D teams — delivered live, online, or tailored to your organization.
From classification to 510(k) submission: a complete, practice-oriented walkthrough of the U.S. regulatory process.
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The Mexican regulatory landscape explained by practitioners — dossiers, timelines, and how to avoid the most common rejections.
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IEC 62304, FDA's AI/ML framework and EU MDR software rules — what innovators must build into their products from day one.
Request syllabus →Compliance shouldn't be a scramble before every audit. IQ Edge monitors regulations, reads your production data, and keeps every project audit-ready — permanently.
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Continuous AI monitoring of FDA, OSHA, ISO and EU updates — mapped automatically to your products and processes.
Evidence, traceability and documentation generated as you operate. Always inspection-ready, never scrambling.
AI-driven gap analysis scores compliance risk per project and recommends prioritized corrective actions.
Alignity IQ was founded on a simple observation: the companies that treat regulation as a discipline — not a checkbox — win their markets. We bring deep regulatory practice and modern AI engineering under one roof.
Whether you need a registration strategy, team training, or a demo of IQ Edge — start the conversation.
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