Industry // Medical Devices

FDA documentation consumes 40% of your quality team's week. The work is manual, repetitive, and one mistake from a finding.

Bloomfield builds custom AI software for medical device manufacturers. Quality documentation tools that understand 21 CFR Part 820 and ISO 13485. Traceability systems that assemble themselves from your existing records. Validation-ready from the architecture up.

The Problem

Regulated manufacturing where the paperwork is as complex as the product

Medical device manufacturing operates under a documentation burden that multiplies with every product line, every customer audit, and every FDA submission. The technical manufacturing is precise. The systems supporting it are held together by manual processes and institutional memory.

Device History Records built by hand

21 CFR Part 820.184 requires a Device History Record for every production unit or batch. Each DHR pulls from incoming material inspection, in-process inspection results, final acceptance testing, labeling verification, and equipment calibration records. Your quality team assembles these from the ERP, the QMS, calibration logs, and paper travelers. A single Class III device DHR can take 4 to 8 hours of manual compilation, and one missing record triggers a nonconformance.

CAPA investigations that start from scratch every time

When a nonconformance occurs, your quality engineer opens a CAPA, investigates root cause, and documents corrective action. The investigation requires searching complaint records, production batch data, supplier history, and previous CAPAs for similar issues. That search happens across an eQMS, spreadsheets, email threads, and physical files. Medical device shops that cannot trace a complaint to a root cause in hours risk FDA 483 observations.

Validation requirements that slow every system change

Every software system that touches production data requires IQ/OQ/PQ validation under 21 CFR Part 820.70(i). That means any new tool your team adopts comes with a validation protocol, execution records, and summary report that can take 6 to 12 weeks to complete. The result: manufacturers stick with spreadsheets and manual processes because the cost of validating something better feels prohibitive.

Traceability gaps that surface during audits

ISO 13485 Section 7.5.3 requires traceability from raw material through finished device. Your auditor asks to trace a specific lot of titanium bar stock from incoming inspection through every machining operation, cleaning step, passivation record, and final packaging. If any link in that chain lives in a system disconnected from the rest, the trace breaks. The systems were never designed to talk to each other.

How Bloomfield Solves It

FDA-aware tools built for medical device manufacturing reality

Every tool we build for medical device manufacturers ships with validation documentation. IQ/OQ/PQ protocols, traceability matrices, and audit trail capabilities are part of the architecture. We build the validation package alongside the software so your quality team does not inherit a 12-week validation project after delivery.

Quoting Agent
Your estimator describes an incoming RFQ for a Class II orthopedic component. The tool surfaces every similar device you have manufactured: materials used, process steps required, quality overhead hours incurred, yield rates experienced, and margins achieved. It flags the validation, cleaning, and packaging requirements specific to the device classification. Quoting a complex implant component that requires passivation, 100% CMM inspection, and biocompatibility documentation moves from a 6-hour exercise to a 90-minute one. Full quoting guide.
Knowledge Engine
Every process validation result, equipment qualification record, cleaning procedure, and inspection technique your quality team has developed gets captured, structured, and made searchable. When a new quality engineer investigates a CAPA, they find every previous nonconformance for that product family, the root causes identified, and the corrective actions that resolved them. The institutional knowledge that keeps your QMS effective survives personnel changes. Full knowledge capture guide.
Production Dashboard
DHR status, lot traceability, in-process hold status, and delivery timelines visible in one place. Data from your ERP, QMS, calibration system, and inspection records merged into a view your production and quality teams share. When an incoming material hold on a titanium lot affects three active work orders, the dashboard shows the impact before anyone manually connects the dots. Full production visibility guide.
Equipment Intelligence
Calibration status, utilization patterns, and process capability data for every piece of production and inspection equipment. A CMM that drifts out of calibration tolerance midway through a production run creates a traceability gap that affects every part measured since the last confirmed calibration. Equipment intelligence flags the drift before it becomes a batch-wide investigation.

What an Engagement Looks Like

Scoped for regulated environments from the first conversation

Medical device manufacturers cannot adopt software the way other industries do. Validation requirements, data integrity obligations, and audit readiness shape every decision. We build with those constraints as the foundation.

  1. Discovery call. You walk us through your operation. What device classes you manufacture, what QMS you run, where documentation consumes the most hours, and what audit findings keep recurring. 30 minutes.
  2. Workflow and compliance audit. We map the specific bottleneck within your regulated processes. DHR assembly, CAPA investigation, lot traceability, quoting. We identify every system that holds relevant data and every handoff where documentation gaps appear.
  3. Validation planning. Before we build, we draft the validation protocol. IQ/OQ/PQ structure, acceptance criteria, and traceability matrix. Your quality team reviews and approves the plan alongside the software specification. No surprises after delivery.
  4. Scoped build with concurrent validation. Working software in 6 to 8 week phases, with validation execution running alongside development. Your team tests against real DHRs, real CAPAs, real production data. We deliver the software and the completed validation package together. What to ask any AI vendor before signing.

Tell us about your operation.

30 minutes. You describe the quality or production bottleneck. We tell you where AI tooling fits, what validation looks like, and what it costs to build.

Book a Call →