Medical Device PCB Assembly

Controlled processes for patient-connected and diagnostic electronics — documentation and traceability built in.

Manufacturing for regulated-minded teams

Medical programs demand consistent workmanship, material pedigree, and clear records. We support Class I–III style builds with lot traceability, ESD controls, and design-freeze discipline.

Discuss your quality agreement, test coverage, and certificate requirements at quotation — we align scope to your regulatory path.

  • Lot and date-code traceability
  • Authorized sourcing for critical ICs
  • AOI, X-ray, and ICT/FCT options
  • IPC Class 2/3 assembly targets
  • NDA before file exchange

How we run your program

Qualify

Review BOM risk, coatings, and test plan.

Freeze

Document approved BOM and revision level.

Build

Controlled travelers and inspection records.

Release

Pack and ship with batch documentation.

PCBA PARTNER at a glance: Manufacturing in Dongguan since 2009; 合品电子 / Hepin Electronics (est. 2016); 2,000㎡ facility; 5 high-speed SMT lines; 50+ staff. About us · Capabilities

Frequently asked questions

Share your certificate requirements in the RFQ — we will confirm current certifications and quality agreements applicable to your project.

Labeling and serialization can be integrated into box build when specified.

ECOs are logged with revision control so only approved BOMs enter production.

Related guides

Request a quote

Send Gerber, BOM, and quantities to hello@pcbapartner.com — typical response within 24–48 hours.

Get a Quote