Our ISO 13485:2016 certified QMS governs every process — from supplier qualification through final device release. Risk management per ISO 14971 is embedded at every stage.
Our quality system is built on three interlocking frameworks that together ensure every board we ship meets the regulatory requirements of FDA, EU MDR, and CFDA markets.
Comprehensive QMS for medical device manufacturing. Covers design control, purchasing, production, traceability, CAPA, and management review. Audited annually by TUV SUD.
Systematic risk analysis across the entire product lifecycle. Hazard identification, risk estimation, evaluation, control, and residual risk acceptance documented per device family.
Software development lifecycle processes for medical device software. Full documentation from software development plan through maintenance. Class B and C software safety classification support.
Our QMS maps directly to the ISO 13485 clause structure. Below are the key operational clauses that our customers interact with during product realization.
Risk management is not a document we file — it is a continuous process integrated into every project phase. We apply FMEA at design, process, and application levels.
Every manufacturing process is validated through installation qualification, operational qualification, and performance qualification — documented and available for your regulatory submission.
Verification that equipment is installed per manufacturer specification. Calibration certificates, utility connections, software version control, and environmental conditions documented.
Process parameter challenge testing at upper and lower limits. Stencil print, placement, reflow profile, wave solder, and cleaning process windows defined and verified.
Production-scale runs under normal operating conditions. Statistical evidence that the process consistently produces conforming output. Cpk > 1.33 for all critical parameters.
Our facility is certified and audited to meet global medical device regulatory requirements.
| Standard / Registration | Scope | Body | Status |
|---|---|---|---|
| ISO 13485:2016 | Design, manufacture, and service of medical electronic assemblies and devices | TUV SUD | Active |
| FDA Establishment Registration | Contract manufacturer of finished medical devices; specification developer | US FDA | Active |
| CE MDD 93/42/EEC + MDR 2017/745 | Annex II and Annex V compliance pathways; MDR transition ready | Notified Body (BSI) | Active |
| IPC-A-610 Class 3 | Acceptability of electronic assemblies — high-performance/harsh environment | IPC (Internal Audit) | Active |
| ISO 14971:2019 | Application of risk management to medical devices | TUV SUD | Active |
| IEC 62304 | Medical device software lifecycle processes | Internal + Customer Audit | Active |
| ISO 10993 (Bio-compatibility) | Via qualified partner labs; material-level testing coordination | Partner: NAMSA / WuXi | Partner Qualified |
| Sterilization Validation | EtO, Gamma, and E-Beam validation coordination per ISO 11135 / 11137 | Partner: STERIS / Synergy | Partner Qualified |
Beyond our in-house capabilities, we maintain qualified partnerships with accredited laboratories for specialized testing and validation services.
We welcome customer and regulatory audits. Quality documentation — including our ISO 13485 certificate, FDA registration, and facility qualification records — is available under NDA.
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