medical

**Yes, we support medical device applications** with **ISO 13485 certified facilities and FDA-compliant processes** — serving medical device manufacturers with chips for patient monitoring (ECG, EEG, pulse oximetry, blood pressure, SpO2, temperature), diagnostic equipment (ultrasound imaging, X-ray, MRI, CT scanners, PET, molecular diagnostics), therapeutic devices (pacemakers, defibrillators, insulin pumps, neurostimulators, drug delivery), surgical instruments (robotic surgery, electrosurgery, endoscopy, surgical navigation), and in-vitro diagnostics (blood analyzers, genetic testing, point-of-care, immunoassays) with ISO 13485 compliant design and manufacturing, biocompatibility testing and certification per ISO 10993, sterilization validation (gamma radiation, ethylene oxide, autoclave), FDA submission support (510(k), PMA, design history file, technical documentation), and long-term supply agreements (10-20 years typical for implantable devices). Medical device services include ISO 13485 compliant design controls (design and development planning, design inputs and outputs, design verification and validation, design transfer, design changes), risk management per ISO 14971 (risk analysis, risk evaluation, risk control, residual risk evaluation), biocompatibility assessment and testing (cytotoxicity, sensitization, irritation, systemic toxicity, implantation), sterilization validation (dose mapping, bioburden, sterility assurance level SAL 10^-6), and regulatory submission support (prepare technical files, respond to FDA questions, support inspections). Medical quality requirements include design controls and risk management (documented design process, risk analysis, traceability matrix), process validation and verification (IQ/OQ/PQ for manufacturing processes, process capability studies), traceability and lot control (complete traceability from wafer to patient, lot genealogy, complaint handling), complaint handling and CAPA (medical device reporting MDR, corrective and preventive actions, trend analysis), and post-market surveillance (vigilance reporting, field actions, product recalls if needed). Medical-grade packaging includes hermetic packages for implantables (ceramic or metal packages, hermetic sealing, helium leak test), biocompatible materials and coatings (titanium, platinum, parylene coating, USP Class VI materials), sterilization-compatible packages (withstand gamma radiation 25-50 kGy, EtO, autoclave 121-134°C), and moisture barrier packaging (aluminum foil bags, desiccant, moisture indicator cards, <10% RH). We've supported 100+ medical device companies including Medtronic, Abbott, Boston Scientific, Philips Healthcare, GE Healthcare, Siemens Healthineers, and Stryker with medical device revenue of $50M+ annually across Class I (low risk, general controls), Class II (moderate risk, special controls, 510(k) clearance), and Class III (high risk, PMA approval, clinical trials) devices. Medical timeline includes design and development (18-30 months with design controls and risk management), biocompatibility and reliability testing (6-12 months for all tests per ISO 10993), FDA submission and approval (6-18 months for 510(k), 12-36 months for PMA), and production ramp (6-12 months with process validation) for total 36-72 months from concept to market — longer than commercial due to regulatory requirements but necessary for patient safety and regulatory compliance with our experienced team guiding customers through complex medical device regulations, quality requirements, and FDA submissions. Contact [email protected] or +1 (408) 555-0270 for medical device design services, ISO 13485 compliance, biocompatibility testing, or FDA submission support.