Medical & Healthcare Solutions
Industry Solution

Medical & Healthcare Solutions

FDA-compliant medical device manufacturing solutions with ISO 13485 certification, precision engineering, and rigorous quality standards for life-critical healthcare applications.

SOLUTION OVERVIEW

Medical Excellence & Healthcare Innovation

Our medical and healthcare solutions deliver life-critical devices and components with uncompromising quality and regulatory compliance. We combine advanced manufacturing with strict quality systems to serve the medical device industry.

ISO 13485
Certification
Medical device quality management system
FDA 21 CFR
Compliance
Full FDA regulatory compliance
Class 10,000
Cleanroom
Controlled manufacturing environment
100%
Traceability
Complete device history record
Medical Device Manufacturing

Medical Device Manufacturing

Cleanroom manufacturing facility with specialized equipment for medical devices, featuring precision machining and comprehensive quality control systems.

KEY FEATURES

Solution Capabilities

Our medical & healthcare solutions delivers comprehensive capabilities designed to address your specific challenges and drive measurable results.

Precision Medical Manufacturing

Ultra-precision manufacturing for medical devices with biocompatible materials and processes.

Regulatory Compliance

Full compliance with FDA, ISO 13485, and other medical device regulations.

Biocompatible Materials

Expertise in medical-grade materials including titanium, PEEK, and biocompatible polymers.

Validation & Testing

Comprehensive validation including biocompatibility, sterilization, and performance testing.

SOLUTION COMPONENTS

Integrated Service Components

Our solution integrates multiple service components to deliver comprehensive value and seamless execution across all project phases.

Surgical Instruments

Surgical Instruments

Precision surgical instruments and tools with superior ergonomics and durability.

Services Included

Precision Machining
Surface Treatment
Sterilization

Technologies

Swiss MachiningPassivationGamma Sterilization
Implantable Devices

Implantable Devices

Orthopedic implants, cardiovascular devices, and other implantable medical components.

Services Included

Biocompatible Manufacturing
Surface Modification
Validation

Technologies

Titanium MachiningSurface TexturingBiocompatibility Testing
Diagnostic Equipment

Diagnostic Equipment

Components for diagnostic imaging, laboratory equipment, and monitoring devices.

Services Included

Precision Assembly
Electronics Integration
Calibration

Technologies

Clean AssemblyEMC ComplianceMetrology

OUR PROCESS

Solution Implementation Process

Our systematic approach ensures successful implementation and optimal results for every medical & healthcare solutions project.

01

Regulatory Planning

Comprehensive regulatory strategy and compliance planning for medical device requirements.

02

Design Controls

Implementation of design controls and risk management throughout the development process.

03

Material Qualification

Biocompatibility testing and material qualification for medical device applications.

04

Controlled Manufacturing

Manufacturing in controlled environments with validated processes and continuous monitoring.

05

Validation & Release

Final validation, documentation, and controlled release with full traceability records.

Ready for Medical Device Excellence?

Partner with us for FDA-compliant medical device manufacturing that meets the highest standards of quality and regulatory compliance.