Get instant, cited answers to complex QA/RA questions

Qalico covers FDA regulations (21 CFR including post-2017 guidance documents), EU regulations (MDR 2017/745 and IVDR 2017/746), MEDDEV guidance, MDCG guidelines and ISO 13485 standards. Our database is updated weekly with new regulations, standards revisions, and guidance documents.

Qalico is trained exclusively on verified regulatory sources including FDA guidance documents, EU MDR/IVDR regulations, ISO standards, and peer-reviewed medical literature from PubMed. Every answer includes direct citations to the original source material so you can verify the information yourself. Our database is updated weekly to reflect the latest regulations and guidance documents.

Qalico delivers synthesized answers in 30 seconds versus 30+ minutes of manual searching. It automatically cross-references related requirements across FDA, EU-MDR, and ISO standards, understanding regulatory context rather than just matching keywords. You can export any answer with full citations ready for technical files or submissions, saving 10+ hours per week on regulatory research.

General AI chatbots are trained on the entire internet including unreliable sources, while Qalico is trained exclusively on verified regulatory documents. Qalico provides direct links to specific sections of official sources, understands device classifications and jurisdiction-specific requirements, and generates compliance-ready exports with full audit trails. Your queries are never used for AI training, ensuring complete confidentiality.

Yes. Qalico can help you conduct structured tasks step by step for gap assessments (comparing your QMS against ISO 13485 or MDR requirements), technical documentation outlines (EU MDR Technical Files, 510(k) submissions), audit checklists (ISO 13485, FDA QSR, or MDR preparation), and predicate identification (510(k) substantial equivalence comparisons). Request access to try out the beta version of the workflow feature.

Yes. Every Qalico answer includes a complete audit trail showing how the answer was generated. You can export answers with full citations, source references, and metadata (document title, section, date accessed, version) in PDF or Word format. This documentation allows auditors and notified bodies to verify any claim and retrace your research process for 510(k) submissions, technical files, and regulatory reviews.

Your queries are completely private and are NOT used to train AI models. All data is encrypted in transit and at rest, and we're fully GDPR compliant. Your search history is accessible only to you, we never share data with third parties, and you can delete any conversation at any time. Your regulatory research remains confidential.

Qalico follows enterprise-grade quality and security standards appropriate for tools supporting medical device registration. We're GDPR compliant with enterprise security infrastructure, and we're working toward ISO 27001 certification and SOC 2 Type II audit. Our development follows IEC 62304 best practices, and we maintain complete audit trails for regulatory research. Under the EU AI Act, Qalico is classified as a decision-support tool with appropriate transparency measures in place.

You can start getting answers in under 2 minutes. Sign up for beta access, verify your email, and ask your first question. No training is required. Most users are productive immediately, finding answers faster than traditional research methods from their very first session.