During Qualera's beta period, all platform capabilities are delivered through MB&A — Qualera's founding operator and a 25-year MedTech QA/RA consultancy. You receive the full power of Qualera's audit intelligence, backed by MB&A's deep regulatory expertise. The client never needs to touch the platform.
Internal audit reports are now FDA-inspectable under QMSR, effective February 2, 2026. CP 7382.850 demands cross-functional, risk-threaded evaluation across your entire quality system. Is your audit program ready?
MB&A plans and executes your internal or supplier audit end-to-end using Qualera. 100% document coverage of SOPs, work instructions, and forms. Full report with findings, regulatory clause citations, document mapping, and complete audit trail.
Your team conducts the audit. MB&A delivers the AI-powered draft report — structured, cited, and ready for your review. You finalize and own the output. Ideal for companies that have audit resources but need the analytical depth and documentation rigor Qualera provides.
Qualera maps your entire QMS against QMSR, ISO 13485, and the CP 7382.850 inspection methodology. Prioritized gap report with finding severity, regulatory exposure, and remediation recommendations. Know exactly where you stand before the auditor arrives.
Under QMSR, management review outputs are FDA-inspectable records. Most MedTech companies are still producing management reviews that look like 2019. That is a compliance exposure. MB&A uses Qualera to analyze QMS performance data and produce a structured, board-defensible management review package. MB&A prepares and stands behind the package. Your quality leader presents and owns it.
Two paths, depending on your situation:
Post-audit sequenced action plan with root cause support, CAPA documentation, and risk-weighted priorities. For planned engagements where you need a clear path forward after a gap assessment or internal audit.
MB&A manages the full FDA response package under deadline pressure. Root cause analysis, corrective action documentation, and response drafting. When you're under the clock, we move at your pace.
Received a 483? Contact us today.QMS due diligence on deal timelines — delivered in days, not weeks. MB&A + Qualera compresses traditional quality due diligence from weeks to days. Structured for PE and strategic acquirer decision-making.
Annual program: one full system audit plus quarterly process-area sweeps. Continuous compliance posture for companies that can't afford a surprise. Retainer clients receive priority scheduling and consistent audit team assignment.
Every engagement starts with a conversation. Tell us about your quality system and we'll recommend the right path.