Solutions / Medical Devices

FDA-sourced AI for medical device
regulatory and quality teams.

Arca helps medical device legal, regulatory, quality, and product teams research 510(k) predicates, MAUDE signals, product classifications, QSR and design-control expectations, labeling and IFU issues, and FDA guidance or rulemaking with answers they can trace back to source records.

Use Cases

Built for the legal work
behind regulated devices.

From pre-submission research to post-market surveillance, Arca helps regulatory, quality, legal, and product teams connect device questions to FDA records, QMS expectations, product risk, and the people who own follow-up.

510(k) Predicate & Clearance Research

Research cleared 510(k)s by product code, device name, applicant, indication, classification regulation, decision history, summaries, and predicate patterns so teams can ground submission strategy in prior FDA decisions.

MAUDE, Recalls & Safety Signals

Research MAUDE reports, device malfunctions, patient injuries, recalls, early alerts, and enforcement materials to spot complaint trends, safety signals, and product risk.

FDA Guidance & Rulemaking

Navigate FDA guidance, CDRH draft guidance, rulemaking, and enforcement history for biocompatibility, cybersecurity, AI/ML, labeling, software, and post-market obligations.

QSR, QMS & Design Controls

Research 21 CFR Part 820, warning letters, and FDA expectations for design controls, CAPA, complaint handling, supplier controls, and production changes.

Regulatory Pathway Comparison

Compare 510(k), De Novo, PMA, and Breakthrough Device pathways against device classification, predicate history, evidence expectations, and precedent decisions.

Labeling, IFU & Claims Review

Draft and review labeling, IFUs, promotional materials, and claims support against current FDA expectations, enforcement actions, and internal standards.

Outcomes

What device teams see
with Arca.

Research

510(k)

Predicate, product-code, clearance, and summary research grounded in FDA source material.

Signals

MAUDE

Adverse event, recall, early alert, and enforcement research connected to product risk.

Impact

QMS

Design-control, CAPA, complaint, supplier-control, labeling, and IFU issues mapped to owners.

Platform

How Arca works for
medical devices.

Arca connects 510(k) research, MAUDE analysis, FDA guidance review, QSR and QMS research, labeling review, and regulatory change impact in one AI layer grounded in FDA and internal records.

510(k) predicate research grounded in FDA device records

Describe your device and ask Arca to identify likely predicates, compare cleared devices, summarize decision history, and pull the details that matter: product code, classification regulation, applicant, indication, decision date, summary, and statement.

510(k)

Predicate, product-code, classification, and clearance research across FDA device records

MAUDE

Adverse event, recall, early alert, and warning-letter research in one workflow

MAUDE and recall signals connected to product risk

Research adverse events by device type, manufacturer, problem code, or event outcome. Arca surfaces trends in complaints, malfunctions, injuries, recalls, early alerts, and enforcement history with links back to source records.

QSR and design-control research tied to QMS impact

Compare 510(k), De Novo, PMA, and Breakthrough Device pathways; research expectations for design controls, CAPA, complaint handling, supplier controls, and production changes; and connect the answer back to FDA source material and your internal QMS context.

QSR

Design-control, CAPA, complaint, supplier-control, and pathway research

Impact

Guidance, rulemaking, recall, standard, label, IFU, and procedure changes mapped to owners

Labeling, IFU, guidance, and rulemaking changes mapped to owners

Arca watches guidance, rulemaking, recalls, early alerts, enforcement signals, standards changes, and procedure updates, then maps what changed back to SOPs, QMS artifacts, labels, IFUs, claims, open questions, and accountable owners.