On the audits where MB&A uses it, Qualera gives the auditor a first read of the documents and records before the work starts. Each finding cites the ISO 13485 or Quality Management System Regulation (QMSR) clause and the passage behind it.
An MB&A lead auditor reviews every finding and keeps it, changes it or rejects it. The platform finds. The auditor decides.
Today, Qualera is available through MB&A, priced per audit. The platform opens to a limited pilot group in November 2026, with wider availability in 2027.
For how it works, who it is for and how it handles your records, go to qualera.ai.