MED-09 · Health Electronics

Wearable stimulation controller

Controlled-output, battery, programmable electronics and electrode or accessory interface architecture.

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ReferenceMED-09SectorHealth ElectronicsEvidenceArchitecture · risks · validation · release packet

Project context

How this product is typically engineered

Controlled-output, battery, programmable electronics and electrode or accessory interface architecture.

System architecture

Typical architecture

Controlled-output, battery, programmable electronics and electrode or accessory interface architecture.

Engineering risks to resolve

Decisions to close before release

  • Define output-load and single-fault behavior.
  • Separate controlled-output, sensing and digital returns.
  • Protect firmware and parameter revision.

Validation plan

Checks to define before production

  • Representative-load and fault-condition testing.
  • Battery, connector, parameter and firmware-state checks.

What to put in the RFQ

Files and records to agree before quoting

Use this list to agree the build inputs and release records for a similar product. The final set depends on the project.

Design baseline

Released schematic or block diagram, interface table, power states, critical constraints, and revision owner.

Manufacturing release

Gerber or ODB++, stack-up, centroid data, assembly drawings, approved DFM dispositions, and panel assumptions.

Material control

Released BOM revision, manufacturer part numbers, AVL or alternate rules, no-substitute lines, MSL handling, and exception approvals.

Validation record

Test method, acceptance criteria, sample or serial identity, measured result fields, and disposition. Example scope: Representative-load and fault-condition testing.

Production release

First-article status plus the agreed SPI, AOI, X-ray, ICT, FCT, programming, rework, OQA, labeling, and packing records.

During RFQ review, we confirm the required fields, sampling, limits, approvals, and record-retention period. Confidential project information stays within the agreed access rules.

Development and production controls

Typical manufacturing scope

  • Controlled-output assembly.
  • Load-test fixture.
  • Configuration control.