Medical Device Electronics
Medical Device PCB Assembly - IPC Class 3 - Traceability
PCB Assembly for Medical Devices - Complete Traceability and Highest Quality
Medical devices require the highest quality standards, complete traceability, and regulatory compliance. Newmatik is your partner for medical device PCB assembly with IPC Class 3 quality, full traceability, and support for MDR compliance.
Your Requirements in Medical Technology
- MDR Compliance: EU Medical Device Regulation
- Complete Traceability: Every component documented
- IPC Class 3: Highest quality standard for critical applications
- Biocompatibility: Clean, flux-free processes
- Long Lifecycle: 10+ years availability
Newmatik Medical Solutions
Complete Traceability
Component-Level Tracking: Every component traceable to manufacturer batch
Process Documentation: Complete recording of all manufacturing steps
Batch Traceability: From incoming goods to finished product
Long-term Archiving: Documentation retention for 10+ years
Support for MDR: Technical documentation for regulatory submissions
IPC Class 3 Quality
We manufacture to IPC Class 3 - the highest quality standard:
- Visual inspection by IPC-certified trained personnel
- X-ray inspection of all BGAs and critical solder joints
- Comprehensive process verification
- Strict acceptance criteria
- Zero-defect mentality
Clean Manufacturing
Conformal Coating: Biocompatible coatings available
Selective Soldering: Clean, flux-free process for sensitive circuits
ESD Protection: Throughout entire manufacturing process
Clean Room Conditions: Available for sensitive assemblies
Application Areas
Diagnostic Devices: Blood analyzers, rapid tests, PCR systems, imaging electronics
Patient Monitoring: Vital sign monitors, ECG, pulse oximeters, temperature sensors
Therapy Devices: Insulin pumps, infusion systems, stimulation devices, laser systems
Laboratory Equipment: Analyzers, centrifuges, microscopes, test automation
Why Newmatik for Medical Devices?
- Complete Traceability: Every component documented
- IPC Class 3: Highest quality standard
- 10-Day Express: Fast prototypes for R&D
- MDR Documentation: Support for regulatory compliance
- Made in Germany: Quality and reliability
- Long-term Partnership: From prototype to series production
- IPC Class 3 Highest quality level
- Complete Traceability Every component tracked
- MDR Compliance Regulatory support