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

Applications & Materials

Metal, plastic and assembled components for portable, handheld, diagnostic and care-related equipment, manufactured to customer drawings and specifications.

PROCH precision medical metal components
PRECISION METAL COMPONENTS
Medical device plastic housing component
PLASTIC MOLDED COMPONENTS
Medical device housing and assembly application
SUBASSEMBLIES
METALPrecision CNC metal components
PLASTICTooling and injection molding
ASSEMBLYMetal, plastic and purchased-part integration
NDAProtection for drawings and project information
Component Categories

Integrated component manufacturing

Manufacturing feasibility for metal parts, plastic parts and modules is reviewed against product function, appearance, tolerance and assembly conditions.

Precision medical metal components
PRECISION METAL

Precision Metal Components

Housings, buttons, bezels, screws, retainers, structural parts and other functional or cosmetic components.

Medical device plastic housing component
INJECTION MOLDING

Plastic Molded Components

Housings, covers, endcaps, buttons and structural parts produced through mold development and injection molding.

Medical device housing and assembly application
SUBASSEMBLY

Subassemblies

Coordinated metal and plastic parts, fixtures, inspection and assembly for module-level production requirements.

Typical Applications

Where these components may be used

PORTABLE MONITORING

Portable Monitoring Equipment

Mechanical housings, internal structures, buttons and precision interfaces for portable or home-care equipment.

HANDHELD DIAGNOSTIC

Handheld Diagnostic Equipment

Cosmetic and functional components requiring dimensional consistency, repeatable fit and controlled appearance.

TREATMENT & CARE

Treatment and Care Equipment

Custom mechanical parts, enclosures and assemblies produced to customer-defined requirements.

Application examples describe manufacturing fit only and do not claim that any displayed part is a finished regulated medical device.

Materials & Process Review

Application areas and commonly reviewed materials

Manufacturing and finishing scope

Material selection is reviewed together with process, tolerance, appearance, mating interfaces and customer-specified requirements.

Manufacturing Scope

  • CNC turning and milling with tolerance control based on drawing CTQs and approved specifications
  • Plastic injection molding including tooling development, mold trials and production-condition control
  • Surface treatment including anodizing, passivation, plating, coating and laser marking through qualified resources as specified
  • Assembly, packaging and lot identification with serial and lot traceability support

Commonly reviewed materials

CategoryMaterial examples
AluminumAL6061, AL6063, AL7075 — structures, housings and heat-dissipation parts
Stainless steelSUS 303, 304, 316L — corrosion-resistant structures and functional parts
Engineering plasticsPC, Tritan, PC+ABS, POM, Nylon — cosmetic and mechanical components
High-performance plasticsPEEK, PPS, PEI, PA66 and others — reviewed by project requirement

Final material and specification selection depends on project drawings, regulatory requirements and supply conditions. Material certificates and lot records can be provided as agreed.

Project Input

Information required for application and material review

Drawings and manufacturing conditions
  • 2D drawings, 3D CAD data and revision status
  • Material specification and customer-assigned regulatory requirements
  • Prototype, pilot and estimated production quantities
Appearance, inspection and assembly conditions
  • Surface finish, color, texture and cosmetic acceptance criteria
  • CTQ dimensions, inspection records and traceability requirements
  • Mating parts, assembly requirements and target schedule
Confidential Projects

Project Information Protection

PROCH respects customer confidentiality. An NDA can be completed before drawings and technical information are exchanged. Sensitive customer designs and project photographs are not published without approval.