In quality and regulatory, the expensive mistakes are quiet ones.
Nothing announces itself. The evidence existed, the reasoning existed, and nobody had time to assemble either under pressure.
THE PROBLEM
One letter can cost a market
A 483 observation costs time and money, can escalate to a Warning Letter, and becomes a public record that follows the site for years.
A submission does not fail loudly
Deficiencies surface weeks after filing, when the fix is expensive and the launch date has already been communicated.
Exposure builds between audits
A quality system drifts quietly. The gap is rarely discovered by the people who own it.
“Every company hits the same problems. The expertise to solve them has never been available at the speed the work demands.”
Mario Wijker, Founder
why this exists
Judgment that scales.
The best regulatory judgment in a company usually lives in one or two people, and it does not scale. VIQERA makes it consistent and available, without diluting it.
Founder — Mario Wijker
25+ years in quality and regulatory leadership
Previously: Boston Scientific, Bio-Rad, Teleflex, Mölnlycke, and Life Technologies
ISO 13485 Lead Auditor and FDA QMSR
Start with the evidence, the risk, and the deadline.
Regulatory disciplines
Three regulatory disciplines. One standard of evidence.
The judgment of senior inspectors and reviewers, on demand.
Inspect
An adversarial mock inspection run against your quality system. You see the 483 the way the agency would write it, while there is still time to answer it. QMSR, ISO 13485, IVDR and MDR.
The question it asks
Show me the objective evidence that this procedure was followed.
Respond
Responses to 483 observations, Warning Letters and Notified Body nonconformances, written to close the finding, not restate it.
The question it asks
What stops this from happening again, and how will you prove it?
Clear
A 510(k) reviewed the way an OPEQ reviewer reviews it, at refuse to accept and at substantive review. Deficiency risk surfaced before the submission leaves your hands.
The question it asks
Why is this predicate appropriate, and where does the comparison break down?
Governance
We start with a conversation, not a pitch. And finish with a decision you can defend.
01
A private conversation
We start with what is keeping you awake before the audit. No pitch, no demo. If the fit is right, we show you exactly how we would reduce the risk you are carrying now.
02
The adversarial run
We put your evidence through the discipline that fits the decision, and give you back what a regulator would find. Every conclusion carries its source.
03
A named expert behind it
Nothing that carries our name reaches you without a person who has earned that judgment standing behind it. Where the evidence is limited, we say so.