The platform
It reads your quality system the way an investigator would.
Qualera reviews your procedures, forms and records against ISO 13485:2016 and FDA's Quality Management System Regulation, and lays out what it finds the way Compliance Program 7382.850 looks at a quality system. Then an auditor goes through every finding.
What it reads
Your procedures and your proof, side by side.
An investigator doesn't stop at whether a procedure exists. They check whether the records show it working. Qualera reads both.
- Procedures
Quality manual, SOPs and work instructions
What your system says it does, checked against what the standard requires.
- Records
Complaints, CAPA, design changes, internal audits and management review
What your system actually did, and whether the pieces connect to each other.
- Suppliers
Supplier document packages
Suppliers upload through a portal before the visit, so the audit starts with a desk review instead of a day of document requests.
What you get
Findings you can check against the record yourself.
- Cited
Every finding names the clause and quotes the passage it comes from.
- Decided
An MB&A auditor keeps, changes or rejects each one, and sets the final severity.
- Consistent
The same report structure on every audit, so results compare year to year and supplier to supplier.
Complaint trends are reviewed every month, but no trend has opened a CAPA in 14 months.
Complaint trends shall be reviewed monthly by the Quality Manager. Escalation to CAPA is at the Quality Manager's discretion.SOP QP-8.2-02, Rev D, section 5.4
Illustration with a fictional company and records. Real findings follow the same format: the clause, the passage it comes from, and an auditor's decision.
How we hold ourselves to it
We test it the way an auditor would be tested.
Before a new release touches a client audit, we run it against the document set of a fictional company. We plant gaps in it, include a few records that look wrong but are compliant, and write the answer key before the run.
The pilot runs under written test protocols. We'll publish accuracy figures once formal validation is complete, and not before. Until then the safeguard is the one that has always mattered in this industry: an experienced auditor owns every call.
What it covers
Clear about what it does today.
Today
ISO 13485:2016 and FDA's QMSR (21 CFR Part 820)
Findings organized the way CP 7382.850 looks at a quality system
Internal audits, supplier audits, mock FDA inspections, gap assessments and due diligence, delivered by MB&A
Works alongside any QMS or eQMS. Nothing to install.
Coming
More device standards
Trends across a whole supplier base
Your own team running reviews on the platform
Wider availability in 2027
EU MDR and MDSAP audits are available today through MB&A, run directly by an auditor.
Questions
What device teams ask us first.
Does Qualera replace our auditors?
No. It gives an auditor a complete first read of your documents and records. An experienced MB&A auditor reviews every finding and decides whether it stands. Nothing reaches you on the platform's say-so alone.
Do we have to change our eQMS?
No. Qualera works alongside the QMS you already have. You share the documents and records in scope, and there is nothing to install, replace or validate to get started.
Which regulations does it cover?
Today the platform reviews against ISO 13485:2016 and FDA's QMSR, organized the way CP 7382.850 looks at a quality system. MB&A audits against EU MDR, MDSAP and customer supplier manuals directly, with an auditor doing that work.
How is it priced?
Per audit, like any audit firm. Tell us about your scope and we'll quote it.
What happens to our documents?
They are handled under a confidentiality agreement and are never used to train AI. Ask us for our data handling answers before you share anything; we will put them in writing for your team.
Can our own team use the platform?
The platform opens to a limited pilot group of device teams in November 2026, with wider availability in 2027. Early-access members are first in line.
Is it built for pharma or biologics?
No. Qualera is built for medical devices only. It is not adapted from drug or biologic rules.
Start here
Tell us about your device and your next audit or inspection.
We'll tell you what Qualera can do for your team right now, and where you'd fit in the platform pilot group.