By late 2025, AI is standard in regulatory readiness workflows. Here’s what high-performing teams are doing—and how to stay ahead.
1) Document intelligence is table stakes
- Automated sectioning, clause mapping, and evidence extraction across MDR, IVDR, and FDA paths.
- OCR + layout understanding to handle scans and legacy PDFs.
- Semantic search over DHF/tech files/IFU to cut prep time.
2) Traceability on-demand
- Live matrices connecting requirements, risks, tests, and labels.
- Instant impact analysis for design changes and CAPA actions.
- Reviewer-ready exports for NB/FDA Q-sub/pre-sub packets.
3) Bias and data quality controls
- Data lineage, access governance, and redaction to protect sensitive info.
- Model monitoring for hallucination control and evidentiary accuracy.
4) Human-in-the-loop remains critical
- RA/QA reviewers approve AI suggestions; auditors expect accountability trails.
- Checkpoints for high-risk claims, cybersecurity, and clinical evidence.
5) What’s next
- Deeper PMCF/PMPF signal detection, proactive labeling checks, and NB-facing consistency scoring.
- Tighter alignment to QMSR/ISO 13485 wording and IVDR PER nuances.
How MedReg AI fits
- Gap analysis mapped to MDR Annex II/III, IVDR Annex XIII, FDA 510(k)/PMA/De Novo.
- Traceability matrices for design, risk, tests, and labeling—exportable for submissions.
- Playbooks for PMS/PMCF, CER/PER, and QMSR transitions.
Start a gap analysis now and share with your NB/FDA prep team. See /pricing to begin or /contact to talk with us.
