Built for medical devices. Only medical devices.

• Quality leaders

  VPs of quality, QA/RA directors and management representatives

  What you are up against. Your team is lean, your QMSR exposure is real, and your internal audits are now records FDA can read. The findings that escalate tend to sit between functions, which is exactly where a stretched team has the least time to look.

  What changes. A complete first read of your system before an investigator gets one, decided by an auditor, so your people spend their hours fixing problems instead of finding them.

• Supplier quality

  Supplier quality engineers and managers

  What you are up against. Dozens of suppliers, a handful of auditors, reports that arrive weeks after the visit and a CAPA list that never shrinks.

  What changes. A desk review of each supplier's package before anyone travels, and every supplier reported in the same format so you can compare them.

• Manufacturers

  Contract manufacturers and component suppliers

  What you are up against. Every OEM customer audits you, each with its own checklist. At many mid-size contract manufacturers the CEO ends up owning the answer.

  What changes. Find the gaps before your customers do, and give them a record that is clean, cited and consistent from one audit to the next.

• Deal teams

  Investors, acquirers and operating partners

  What you are up against. A device company's quality system is part of what you are buying, along with its FDA history and whatever an investigator finds next.

  What changes. Quality due diligence that tells you what FDA would find, written so a board can act on it.

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