Who we serve

Medical device companies at three stages.

What we do is the same: audits and remediation done right. Where we start depends on the size of the company.

Early stage

Startups

Embedded fractional quality and regulatory support, with quality strategy through the 510(k) and first launch.

$40M to $300M

Mid-size device makers and contract manufacturers

Remediation, audits, and quality system ownership, for original equipment manufacturers (OEMs) and contract manufacturers whose quality system has to keep up with growth.

Remediation Audits

Above $300M

Large OEMs

Supplier quality: audit programs, oversight, and transfer support, run as an ongoing program.

Supplier audits

Tell us what FDA, an auditor, or your own team found. We will tell you how we would handle it.

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