BotableBook a call

In medical devices, the manual step is there for a reason.

Systems changes are expensive. So the work around the record stays manual, and skilled quality time goes with it. Botable builds and runs the AI layer that takes it back, without touching the official state. The decisions stay with your team.

Start with one gap

The conditions changed. Your headcount did not.

A new quality framework, a new inspection process, and a document set that keeps growing. Your team carries all of it at once.

  1. QMSR is in effect. QSIT is retired.

    Both happened on 2 February 2026: QMSR took effect, and FDA retired QSIT and moved device inspections to a new process. Your team carries that transition on top of the work it already had, and the work around the official record has to stay aligned the whole way through.

  2. A change has a blast radius.

    One revision can reach SOPs, drawings, bills of materials, training, and supplier records. Acting on these records can be burdensome.

  3. The device and its build record can travel separately.

    When a contract manufacturer assembles the device, the product and its build record can move on different timelines. Your team may be left to reconcile them by hand before the picture is complete.

  4. Retraining is a coordination job nobody was hired for.

    One controlled-document revision can put required training in front of every affected role. At scale, the burden is not the content. It is the coordination: the notifying, the reminding, and knowing where everyone stands, week after week.

  5. The CSA update names AI and machine learning.

    FDA updated its Computer Software Assurance guidance on 3 February 2026 to align with QMSR. It addresses AI and machine learning used in production and quality management, expands its recommendations on vendor oversight, and clarifies when 21 CFR Part 11 applies.

The work moves around the record. Never through it.

  1. Official record

    Your systems remain the authority.

    Controlled documents, product definitions, training assignments, approved changes: they live in your eQMS and PLM, and that is where they stay.

  2. Work around it

    The AI layer assembles the picture.

    It reads current records, traces what a change touches, prepares the follow-through, and puts the differences side by side. It presents. It does not act on the record.

  3. Human decision

    What changes is your team's call.

    Impact, disposition, approval, and any action inside a validated system: each one belongs to a person on your team, by name. Go-live does not change who decides.

Three ways in. Each is one gap wide.

Each begins with one recurring task around the systems that already hold your record.

  1. When one change reaches farther than one record

    Change Order Management

    It traces everything a proposed change touches and lays out the full impact before review begins. Deciding, and acting on the record, stay with the accountable team.

  2. When the training is known and the chasing is manual

    Training Notification Orchestration

    It carries a known training need through notification, reminders, and escalation, in the messaging app your team has open all day. Follow-through becomes something you can see, not something you chase.

  3. When every complaint waits for a person to read it

    Complaint Analysis

    It suggests a code from the complaint's own words and shows the source passage beside it. The analyst approves every code and keeps the reportability call.

Related work

Bring us the work your quality system leaves to people.

We map the work, build the AI layer on the systems that hold your record, and stay to run it, through the QMSR transition and whatever follows it.

Start with one gap