QMSR Exposure Check

Answer ~10 quick questions and get a deterministic read on where your quality system is most exposed to FDA enforcement — mapped to current ISO 13485 / FDA QMSR citations. No fluff, no AI guesswork.

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Company name (optional)

Highest device class

Regulatory pathways

510(k)

De Novo

PMA

HDE

510(k)-exempt

Markets

United States (FDA)

European Union (MDR)

Canada (Health Canada)

Australia (TGA)

Japan (PMDA)

Brazil (ANVISA)

China (NMPA)

United Kingdom (MHRA/UKCA)

Key processes

Design & development

Software / SaMD

Electromechanical manufacturing

Implantable device

Sterile / sterilization

Manufacturing / production

Outsourced / supplier-dependent

Complaint handling / post-market

Servicing / installation

We are ISO 13485 certified

We have an open FDA Form 483 or Warning Letter

This is a self-assessment screening — not an audit finding or regulatory observation. Scores are qualitative estimates and do not predict fines, penalties, or inspection outcomes.

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VirtualBackroom.ai provides regulatory compliance coaching and training support. It is not a substitute for professional regulatory consultation, legal advice, or formal audits. Do not rely on AI outputs for official compliance decisions without independent qualified human review.

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