CP 7382.850 demands cross-functional, risk-threaded evaluation across every QMS area — simultaneously. No manual process catches that. No eQMS was designed for it.
Qualera was.
During beta, all Qualera capabilities are delivered through MB&A — Qualera's founding operator and a 25-year MedTech QA/RA consultancy. Full audits, gap assessments, management review preparation, remediation support, and quality due diligence. You get the analytical power of Qualera and the expertise of MB&A. You never need to touch the platform.
34,000 FDA-regulated establishments run quality on static documents and manual processes. The average 483 observation costs $5 million. QMSR made internal audits inspectable. And the findings that escalate to warning letters — the cross-functional linkages between complaints, CAPAs, design changes, supplier performance, and management review — are the ones no manual process catches reliably.
Quality controls that aren't controlling anything — static activities that check a box while the real risks compound underneath.
Qualera deploys specialized AI agents to audit your entire quality system — with cross-functional reasoning, adversarial review, and human-in-command oversight. Built on the largest pool of FDA regulatory data ever assembled.
Each modeled after a real-world audit role. They analyze in parallel, trace evidence threads across QMS domains, and validate every conclusion through adversarial review.
Warning-letter-level findings are cross-functional. Qualera maps the connections between complaints, CAPAs, design changes, and supplier performance — simultaneously.
A dedicated adversarial agent challenges every finding for false positives, proportionality, and blind spots — before a human makes the final call. Audit methodology, not automation.
Every finding comes with evidence, regulatory basis, adversarial challenges, and confidence scores. You review. You decide. Regulatory accountability stays where it belongs.
Qualera reads everything in your eQMS and reasons across it. Your eQMS is the library. Qualera is the audit team that reads every book and tells you what's connected.
Structured in alignment with FDA's current inspection methodology. Not adapted after the fact — designed from this framework from day one.
Qualera conducts comprehensive, evidence-grounded FDA quality system audits the way an elite audit team does — with parallel analysis, cross-functional reasoning, and human oversight at every step.
Qualera integrates with your existing quality management system. Upload documents or connect directly. Your data stays yours — encrypted, isolated, never used for training.
Select which regulatory requirements to audit against — ISO 13485, QMSR, EU MDR, MDSAP. Qualera configures the right expert panel for your device type, classification, and inspection model.
Specialized agents analyze every QMS area simultaneously — tracing evidence threads, mapping cross-functional connections, and challenging each other's findings through adversarial review.
Every finding arrives with the evidence analyzed, the regulatory basis applied, adversarial challenges raised, and a confidence score. Approve, modify, or reject. You are always in command.
Export comprehensive audit reports with prioritized findings, gap analysis, specific regulatory references, and corrective action recommendations your board and regulators can trust.
Qualera is purpose-built for the medical device regulatory framework — ISO 13485, FDA QMSR, EU MDR, MDSAP. Not pharma. Not biologics. Not adapted from another industry. Built by a 25-year MedTech quality veteran who spent decades in the audit room before building the platform.
VP Quality, Quality Directors, Sr. Quality Managers
Drowning in audits, understaffed, reactive. QMSR made internal audits inspectable and the cross-functional findings that escalate are impossible to catch manually. Qualera amplifies your judgment — it doesn't replace it.
Operating Partners, Portfolio Quality Leaders
Device acquisition diligence takes 3–6 weeks and a team of consultants. Qualera compresses that to days — with 100% document coverage and the cross-functional risk mapping that manual reviewers miss.
Investment Banks, Device-Focused PE/VC
QA/RA is the slowest diligence workstream. Findings emerge late. Deals die. Qualera delivers comprehensive findings in days, not the week before close.
Limited beta launches April 2026. Full platform launch December 2026. Join the early access list for priority onboarding and product previews.
AICA serves pharma and biologics. Qualera serves medical devices — a fundamentally different regulatory framework. But the architectural difference is more fundamental: AICA retrieves answers from a static knowledge base. Qualera reasons about compliance using specialized agents with adversarial review and cross-functional tracing. Different market. Different architecture. Different category.
They store documents and manage workflows — designed around isolated QMS modules. CP 7382.850 now demands cross-functional, risk-threaded evaluation across all six QMS areas simultaneously. That's structurally impossible in a document management system. Qualera is the intelligence layer that reads everything and reasons across it. Your eQMS is the library. Qualera is the audit team that reads every book and tells you what's connected.
A wrapper sends a document to a single model. Qualera deploys specialized agents across four architectural layers. Dual-model peer analysis. Dedicated evidence validation confirming every citation. Adversarial review stress-testing for false positives. Multiple phases of validation before a human sees anything. That's not a wrapper. That's an audit team.
Your data is encrypted at rest and in transit, isolated per customer, and never used for model training. Qualera is built for the most regulated industry in the world. Security and data sovereignty are not features — they're the foundation.
Limited beta launches April 2026, with full platform launch in December 2026. Nine Founder's Circle members and design partners are already building with us. Early access requests receive priority onboarding.
Qualera was built by Monica Burt, a 25-year MedTech quality and regulatory veteran and founder of MB&A. She spent decades in the audit room before building the platform the industry needs. This isn't a tech company that discovered healthcare is a big market. It's a quality leader who built the intelligence platform she always wished existed.
Whether you're ready to see the platform or just want to understand how Qualera fits into your quality strategy, we'd like to hear from you. We'll follow up within one business day.