From regulatory assessment and risk classification to a complete 510(k) submission in eSTAR. 40 live hours using a real case study, with AI applied at every stage - always under human validation.
40 live hours, with applied AI
AI multiplies productivity in Regulatory Affairs: classification research, dossier writing, gap analysis and checklists. Used without judgement, however, its errors are costly. This course teaches you to accelerate safely - and you leave with a real 510(k) submission assembled from end to end.
Five profiles gaining technical independence in the US market - and speed with AI.
Who need to master the FDA pathway to accelerate their products' access to the US market.
Planning to sell in the USA and seeking to anticipate timelines, costs and market entry strategy.
Responsible for regulatory obligations before FDA.
Involved in design, submission and post-market activities.
Seeking to structure an FDA-focused service offering - with AI increasing productivity.
By the end of the course, you will master the complete FDA registration lifecycle - and know where AI accelerates each stage.
| # | Competency | What you deliver |
|---|---|---|
| 01 | Regulatory assessment and classification | Classify any device by risk class, with the correct product code and regulation number. |
| 02 | Market pathway | Select 510(k), De Novo, PMA, HDE or an exemption - and justify the decision. |
| 03 | User fee savings | Reduce MDUFA user fees through Small Business Determination, including as an overseas manufacturer. |
| 04 | Dossier and eSTAR | Assemble the technical dossier and eSTAR submission, from the predicate to the technological comparison. |
| 05 | QMSR and design controls | Connect QMSR and design controls (DHF/DMR/DHR) to submission content. |
| 06 | UDI and GUDID | Compose the UDI and register the DI in GUDID - with a live screen demonstration. |
| 07 | Post-market | Plan labelling, MDR, recalls and post-market surveillance. |
| 08 | Applied AI | Accelerate each of these tasks with AI - verifying every output against official sources. |
The modules build on a single case study (Class II device) through to a complete 510(k) submission. Each includes a practical AI application within a real regulatory workflow.
Understand the FDA structure (CDRH) and classify your device by class, product code and regulation number.
Choose between 510(k), De Novo, PMA, HDE and exemptions - and reduce costs through Small Business Determination.
Structure the submission: predicate comparison, bench testing, biocompatibility and assembly in eSTAR.
Connect the quality system (QMSR/ISO 13485) and DHF/DMR/DHR to submission evidence.
Meet labelling requirements, compose the UDI and register the DI in GUDID - with a live screen demonstration - and plan MDR and recalls.
Assemble the case study's complete submission and defend it before a panel.
Responsible acceleration. AI does not replace the RA professional - it multiplies their capacity. You learn the safeguards that keep it safe in regulatory work.
Research and screening (classification, product codes, predicate candidates); assisted writing (dossiers, technological comparisons, responses to deficiency letters); analysis (QMSR × ISO 13485 gap analysis, eSTAR and GUDID checklists); and technical Portuguese-English translation for overseas manufacturers.
Mandatory verification against official sources (eCFR, fda.gov); confidentiality and LGPD (sensitive data must never be entered into public AI tools); human-in-the-loop (regulatory decisions always remain with the professional); traceability of every output to its legal basis.
AI drafts, suggests and checks. Regulatory decisions - market pathway, classification and final submission content - always remain with the professional. You leave the course knowing how to use AI as an experienced copilot, with technical independence.
Your company may pay considerably less to FDA. CDRH's SBD programme reduces or waives MDUFA user fees for smaller businesses - including overseas manufacturers. You learn the eligibility thresholds, the CDRH Portal procedure and the specific pathway for Brazilian manufacturers.
From concept to screen: see the complete DI registration workflow in GUDID live - account, attributes, publication and common errors - and learn to compose the UDI (DI + PI) under 21 CFR Part 801 and Part 830.
No endless lectures. Each session alternates short conceptual blocks, live screen demonstrations and guided practice - with pre-work and post-work to consolidate learning.
At least 40% of the time spent on practical activity, with interaction every 15-20 minutes: a question, poll or mini-case. Breakout rooms with written instructions, a defined time and a deliverable.
Classification Database, eSTAR and GUDID registration demonstrated in real time - see the official tool working, with the instructor navigating each field.
One device (Class II) developed module by module through to a complete 510(k) submission. Leave the course with a real deliverable - more than a classroom exercise.
The course is delivered by HSC Global Group's senior Regulatory Affairs consultants, with medical device regulatory expertise and live-course experience. All content is produced with AI support and validated by an RA/RTP specialist before each cohort - the same verification discipline we teach in class.
Your questions about the FDA Medical Device Registration with AI course answered.
Cohorts are limited to 25 participants to ensure real breakout-room practice. Leave the course with a 510(k) submission assembled and defended before a panel - with AI working in your favour.
This is an educational course. Regulatory decisions for a specific product require case-by-case analysis by a specialist. The certificate attests to participation and achievement; it is not a regulatory opinion.
