The whole FDA compliance.
The quality system and the cybersecurity, end to end.

The full quality system: procedures, design history file, risk file, CAPA, supplier controls and training records, built with you and kept current. The QMSR rule folded ISO 13485 into US law on 2 February 2026, so it is the same work either way. The certification audit itself is done by an accredited registrar, because we can never be your auditor.

For any device with software that can connect to anything, four things: a postmarket plan to monitor vulnerabilities with coordinated disclosure, a process to patch on a regular cycle and ship critical fixes out of cycle, a software bill of materials, and whatever the FDA adds by rule. It has been enforced since October 2023, and the submission carries a cybersecurity section with ten parts that have to agree with each other.

Yes, on every release, run by our own engine, with the report going into the package. Firms that sell the test separately usually charge between $15,000 and $90,000 for it. For connected hardware, a partner lab runs the wireless and hardware tests, about $15,000 paid to the lab, and we fold their report into the same package.

Yes. If you already run a quality system in Greenlight Guru, Qualio or another eQMS, keep it: we do the section 524B package and the penetration test, and export a controlled, versioned document package that you file into the system you already have. That is $1,250 a month for one device. Talk to the founders and we will scope it with you.

That is the point: one platform and one team. We build the quality system and the cybersecurity with you, run the pentest, and introduce you to the accredited labs and the regulatory expert for the rest. We also walk you through establishment registration, device listing and UDI. The FDA, the labs and the registrar bill you directly.

We introduce you to accredited labs for whatever your device needs: electrical safety and EMC (IEC 60601), biocompatibility (ISO 10993), usability (IEC 62366), wireless coexistence, and bench or clinical data. We plan the testing with you and add every report to your submission. Lab fees are extra and billed by the lab.

You pay them directly. The FDA's user fee goes to the FDA, each lab bills its own tests, and the ISO 13485 audit goes to the accredited registrar. None of it goes through us and we do not take a share, because a fee split would compromise the independence that makes their results worth anything.

We start from what you already have, your code, your build and your diagrams, instead of a blank page. How long the whole submission takes depends on your device, which tests it needs, how complete your records are and how fast the FDA reviews it. We will give you a straight answer on the call.