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.
Qualera launched in September 2026 and is available today as a service 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. In November 2026, the SaaS platform opens to a limited pilot group.
Most device makers still run quality on static documents and manual processes. 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 reviews your entire quality system, every procedure and record, against ISO 13485 and the FDA Quality Management System Regulation (QMSR). Every finding cites the clause and the source passage. MB&A auditors review and decide every finding.
Every procedure and record, reviewed against ISO 13485 and QMSR. Not a sample. Complaints, CAPAs, design changes, supplier controls, and management review are all in scope.
Warning-letter-level findings rarely sit in one place. Qualera's findings show where complaints, CAPAs, design changes, and supplier performance don't line up.
Each finding cites the ISO 13485 or QMSR clause and the source passage in your documents. You see the evidence behind it, not just a conclusion.
The platform finds. The auditor decides. MB&A auditors review and decide every finding before it reaches you. Regulatory accountability stays where it belongs.
Qualera works with the eQMS you already have and reviews everything in 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 around this framework from day one.
Qualera conducts comprehensive, evidence-grounded FDA quality system audits. Every procedure and record is reviewed, every finding is cited, and an experienced auditor stays in command of the result.
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 scopes the review to your device type, classification, and inspection model.
Qualera reviews every procedure and record in scope against the standard you selected. Nothing is sampled. Each finding is tied to the clause it concerns and the passage it comes from.
Every finding cites the clause and the source passage, so you see the evidence behind it. MB&A auditors review and decide every finding before it reaches you. The platform finds. The auditor decides.
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 to 6 weeks and a team of consultants. Qualera compresses that to days, with every document reviewed and every finding cited to its source.
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.
Qualera launched in September 2026 and is available today through MB&A. In November 2026, the SaaS platform opens to a limited pilot group. Request early access for priority consideration for the November pilot.
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 works alongside your eQMS and reviews everything in it. Your eQMS is the library. Qualera is the audit team that reads every book and tells you what's connected.
No. Qualera reviews your whole quality system, every procedure and record, against ISO 13485 and the FDA QMSR. Every finding cites the clause and the exact source passage, so you can check the evidence yourself. And an experienced MB&A auditor reviews every finding before it reaches you. The platform finds. The auditor decides.
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.
Qualera launched in September 2026 and is available today as a service through MB&A. In November 2026, the SaaS platform opens to a limited pilot group, with broader availability in 2027. Early access requests receive priority consideration for the pilot.
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.
Qualera is the platform. MB&A is the consultancy that built it and delivers every engagement. The Quality Signal is where the lessons get published.
25 years and 300+ FDA and ISO audits. The MedTech audit and remediation practice that operates Qualera on behalf of clients.
Visit MB&AThe new era of quality is here. Built from inside the industry, for the industry.
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