Studio Technology Co., Ltd.
| Packaging Details | ESD Protective Packaging/Customization |
| Delivery Time | 5-25 working days(varies by product) |
| Supply Ability | 100,000 pieces/month |
| Payment Terms | T/T |
| Place of Origin | China |
View Detail Information
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Product Specification
| Packaging Details | ESD Protective Packaging/Customization | Delivery Time | 5-25 working days(varies by product) |
| Supply Ability | 100,000 pieces/month | Payment Terms | T/T |
| Place of Origin | China | ||
| High Light | iso turnkey prototype assembly ，medical device pcb design iso ，turnkey prototype assembly 100% tested | ||
Medical device development demands quality that meets rigorous standards—even for low-volume production runs. Studio Electronics offers Medical PCB SMT Assembly with turnkey service designed for the unique requirements of medical device development. As a specialized provider of PCB assembly in China, we apply ISO13485-compliant quality management to low volume PCB assembly, ensuring full traceability, documented quality, and reliability from order receipt through component procurement, fabrication, assembly, testing, and shipping. Our 12 automated SMT lines, automatic wave soldering, programmable soldering robots, and comprehensive inspection suite deliver medical-grade quality for clinical trial batches, pilot runs, and regulatory testing.
| Stage | Process Description | Medical-Device Quality Control |
|---|---|---|
| 1. Order Receipt | Design file review; BOM validation; DFM analysis | Documented review; risk assessment; design control |
| 2. Component Procurement | Medical-grade components; authorized distributors | Full traceability; supplier certification verification; incoming inspection |
| 3. PCB Fabrication | In-house etching, layering, drilling | Controlled processes; material certifications; documented parameters |
| 4. SMT Assembly | 12 automated SMT lines; ±25μm accuracy | Documented process controls; 100% inspection; zero-defect focus |
| 5. Quality Inspection | 100% coverage: AOI, X-Ray, ICT, Flying Probe, FCT | 100% testing; reliability lab testing; full documentation per board |
| 6. Final Assembly | Board integration; component connection; final verification | Documented procedures; final verification; traceability records |
| 7. Shipping | Anti-static packaging; customs clearance | Documentation package; audit-ready records; certified shipping |
ISO13485-Compliant Quality – Our quality systems are built for medical device regulatory requirements
Full Traceability – Every board receives a unique serial number linked to component lot numbers and test results
Reliability Laboratory – Environmental testing including thermal shock, temperature cycling, damp heat, and vibration
Documentation Support – Complete quality records for every board, supporting FDA/QSR submission requirements
Low Volume Expertise – Low volume PCB assembly for clinical trial batches; small quantities for regulatory testing
Patient monitoring devices
Diagnostic equipment
Wearable health devices
Laboratory instruments
Point-of-care testing devices
Implantable device prototypes
| Medical Requirement | Studio's Capability |
|---|---|
| Regulatory Compliance | ISO13485-certified quality management; audit-ready documentation |
| Full Traceability | Component lot numbers; test results; serial-level records |
| Reliability Validation | Environmental testing; functional testing; 100% inspection |
| Confidentiality | IP protection; NDA standard practice; controlled access |
| Low Volume Support | Low volume PCB assembly for clinical trials; small batches |
Studio delivers Medical PCB SMT Assembly—turnkey service with ISO13485-quality for medical device development.
Company Details
Business Type:
Manufacturer
Year Established:
2003
Total Annual:
30000000-40000000
Employee Number:
300~500
Ecer Certification：
Verified Supplier
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