Medical device quality and regulatory consulting
We get the hard quality problems right, so patients stay safe.
Audits of every type, and the remediation that closes what they find. 25 years in medical device quality, and more than 300 audits against FDA, ISO, MDSAP, and other global regulations.
Door one
Audits
Mock FDA, internal, and supplier audits, and quality due diligence. Findings ranked, specific, and ready to act on.
Explore auditsDoor two
Remediation
483 and warning letter response, CAPA, QMS and design history file remediation, and field actions. The fix, not just the finding.
Explore remediation- 25years in medical device quality and regulatory work
- 300+audits against FDA, ISO, MDSAP, and other global regulations
Our promise
We stick with it until it is done, and done right.
From finding to fixed to proven
- 1
Find
Audits that show the whole picture, ranked by risk.
- 2
Fix
Remediation run by the same team, to plan and to budget.
- 3
Prove
Records an auditor or investigator can follow without us in the room.
- 4
Sustain
Quality systems and supplier programs that keep the result in place.
What makes MB&A different
Industry insiders turned innovators
Our people ran quality inside device companies before they audited anyone else's. We did not stop at finding problems. We built Qualera to fix them.
Speed that restores control
We deploy fast, so you get control of the situation back sooner.
Partnership with complete transparency
Our success is tied to yours the whole way through.
More ways we help
Quality Systems Management
Build, fix, or operate the quality system, sized for the company, not over-engineered.
Read more →Regulatory Affairs
FDA, EU MDR, and global market access strategy, with timelines you can plan around.
Read more →Operations and Engineering
Manufacturing readiness, process validation, supplier quality, and design transfer.
Read more →Startup Partnership
Embedded fractional quality and regulatory support for early-stage medtech, from first strategy through first launch.
Read more →