Medical Device

Manufacture Devices Patients Depend On

Connect Design Controls, Production, and Post-Market Evidence in One System

Compliance Woven Into Execution

Medical device regulations require traceable changes, validated systems, and clear accountability. Apprentice supports electronic records, signatures, and structured workflows aligned to quality system expectations — so evidence is generated as work happens, not reconstructed after the fact.

Product Lines Evolve Under Scrutiny

Labeling changes, supplier updates, and design revisions must be controlled. Apprentice helps you manage effectivity, training, and shop floor execution together — reducing the risk of building to the wrong revision during high-pressure ramps.

Connect Manufacturing to Quality and PLM

DHF and DMR alignment depends on connected data. Apprentice integrates across PLM, ERP, and QMS so travelers, inspections, and nonconformances stay linked. Accelerate investigations and CAPAs with context-rich records operators can trust.

AI Agents for Medical Device

A1's sub-agents automate the work Medical Device teams spend hours on manually.

Things you can do today, but faster.

Active Troubleshooting GuideGenerate a step-by-step troubleshooting guide for repeated issues on Device Assembly Line 3 using the relevant procedures, equipment manuals, and current production context.
Multi-File SOP Quick-ReferenceI uploaded the core procedures for this line. Find the exact sections required before restarting the cell and generate a step-by-step operator guide.
Equipment Setup GuideExtract the startup, setup verification, and pre-run checks from the relevant equipment manuals for today's production run on Device Assembly Line 3.

Workflows you never thought possible.

Process Drift AnalysisAnalyze the last 30 days of production data for this line. Identify any drift in critical variables and generate a trend report showing where performance is moving out of its expected range.
Throughput & Rework Improvement ReviewCompare the last three production runs, isolate the biggest losses in throughput and rework, and show me the best operator-level improvements for the next run.
Shift SummaryEvery day at 6:45 PM, review the latest relevant records across work instructions, eDHR records, inspection results, and tester logs, then generate a summary with priorities, blockers, and follow-up items.

From Design Transfer to Sustaining Operations

Design Transfer

Industrialize the Design Intent

Turn approved outputs into repeatable manufacturing and test methods.
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Transfer is where great designs succeed or fail in production. Apprentice helps teams structure work instructions, fixtures, and validation evidence so the line reflects what engineering released.

Commercial Manufacturing

Scale with Controlled Variation

Standardize execution while capturing exceptions with full traceability.
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As demand grows, consistency matters more. Apprentice supports batch and serialized builds with clear genealogy, inspection plans, and release criteria aligned to your QMS.

Global Supply & Partners

Keep Partners Aligned to Your Standard

Extend controlled procedures across internal sites and contract manufacturers.
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Medical supply chains are tightly regulated. Apprentice makes it easier to harmonize templates, audit performance, and respond to changes without breaking traceability.