MEDICAL DEVICE PRODUCT DEVELOPMENT | ISO 13485 QUALITY SYSTEM | OEM / ODM
Portable Device Components

Metal, plastic and assembled applications

MEDICAL PARTS

Precision Medical Components

Metal and plastic housings, structural parts, buttons, screws, retainers and critical functional components for portable medical devices.

  • CNC machining and dimensional control
  • Injection molding and appearance management
  • Inspection and assembly verification
CONSUMER PARTS

Consumer Equipment Parts

Precision metal and molded components for coffee equipment, electronic accessories and product development programs.

  • Tooling and injection molding
  • Surface treatment and finishing
  • Fit, function and batch consistency
TURNKEY PRODUCTS

Integrated Finished Products

Cross-disciplinary product realization from industrial, mechanical and electronic design through manufacturing and assembly.

  • Product definition and engineering
  • Prototype and design verification
  • Production transfer and assembly
Case Studies

Productization shown through engineering outcomes

CASE 01 | SEALING & LEAKAGE

Identifying the dimensional chain that controls sealing

CHALLENGE

Assembly leakage could not be explained by checking a single component dimension.

ENGINEERING ACTION

Reviewed datum strategy, tolerance stack, sealing-interface geometry and inspection method.

RESULT

Critical dimensions and inspection controls were transferred into production documentation.

CASE 02 | ASSEMBLY & YIELD

Reducing manual variation through DFA

CHALLENGE

Manual orientation and fitting created inconsistent assembly time and yield.

ENGINEERING ACTION

Improved mistake-proofing, assembly sequence, dedicated fixtures and in-process checks.

RESULT

A clearer, repeatable assembly process suitable for pilot and production stages.

CASE 03 | DESIGN TRANSFER

Converting engineering samples into production specifications

CHALLENGE

Prototype knowledge had not yet been converted into controlled manufacturing data.

ENGINEERING ACTION

Released drawings, BOM, CTQ, SOP, tooling and inspection requirements as one transfer package.

RESULT

Engineering intent was preserved through pilot production and production introduction.