MEDICAL DEVICES

Calpak USA operates under an ISO 9001 certified quality management system that incorporates procedures aligned with the documentation and process control expectations of FDA 21 CFR Part 820 for medical device current good manufacturing practice. Our Hawthorne, California facility enforces validated manufacturing processes, incoming material inspection against approved vendor lists, in-process statistical monitoring, and final acceptance testing with documented pass-fail criteria. Design history file documentation, risk analysis inputs per ISO 14971, and corrective action procedures are maintained for every medical device program. Calpak USA's AS9100 Rev D certification adds an additional layer of rigor through aerospace-grade configuration management and nonconformance disposition protocols. For medical OEM procurement teams evaluating contract manufacturers, this combined framework provides assurance that assemblies are produced under controlled, repeatable conditions suitable for regulated medical device applications.

Calpak USA captures component-level lot traceability on every medical device assembly, recording supplier lot codes, date codes, certificates of conformance, and moisture sensitivity level data at incoming inspection. Throughout production, our MES system logs operator identification, machine parameters, solder paste lot numbers, reflow profile data, and inspection results for each serialized unit or lot. This information forms the core of the device history record that medical OEMs require under FDA 21 CFR Part 820.184. At our Hawthorne, California facility, Calpak USA retains these records for the customer-specified retention period, typically matching the expected device lifecycle plus regulatory holding requirements. When a field issue arises or an FDA audit requires documentation, Calpak USA can produce complete traceability packages linking any finished assembly back to its constituent materials, process steps, and quality disposition within the same business day.

Calpak USA has manufactured PCB assemblies and electro-mechanical sub-systems for both Class II devices such as patient monitoring equipment, infusion pump controllers, and diagnostic instruments, and Class III life-sustaining devices including implantable pulse generator chargers and critical-care therapeutic platforms. The distinction matters because Class III devices undergo premarket approval with stricter manufacturing controls and validation requirements. Calpak USA's production processes in Hawthorne, California accommodate these elevated requirements through formal process validation protocols, enhanced in-process inspection gates, and 100 percent functional testing with documented acceptance criteria traceable to the device master record. Our quality team collaborates with medical OEM regulatory affairs departments to ensure that manufacturing documentation packages satisfy FDA submission requirements, providing the objective evidence of process capability and product conformance that auditors expect during facility inspections.

Calpak USA maintains an ANSI/ESD S20.20 compliant electrostatic discharge control program throughout our Hawthorne, California production facility, which is critical for medical device assemblies that often incorporate sensitive analog front-end circuits, microcontrollers, and precision sensor interfaces. Our ESD program includes continuously monitored workstation ionization, wrist strap integrity verification systems, conductive flooring and footwear grounding, and humidity-controlled manufacturing areas. All operators handling medical device assemblies wear tested ESD smocks and wrist straps, with compliance logged electronically. Incoming components are stored in ESD-protective packaging within our humidity-controlled stockroom, and transfer between workstations uses shielding bags and conductive totes. Calpak USA conducts quarterly ESD audits and annual recertification testing on all protective equipment. For medical device assemblies where a single ESD event could create a latent defect leading to field failure in a patient-contact device, this disciplined program is essential.

While AS9100 Rev D was developed for aerospace, its requirements for configuration management, risk-based thinking, supplier controls, and product traceability directly address pain points that medical device manufacturers face under FDA regulatory scrutiny. Calpak USA's AS9100 certified processes at our Hawthorne, California facility provide medical OEMs with formalized engineering change control procedures that prevent unauthorized modifications to validated production processes. The standard's requirements for documented work instructions, operator qualification records, and calibrated inspection equipment align closely with the design transfer and production controls expected under 21 CFR Part 820. Medical device companies working with Calpak USA benefit from a contract manufacturer already operating at a quality tier that exceeds typical commercial electronics shops. This means fewer audit findings, faster supplier qualification timelines, and reduced risk of manufacturing-related nonconformances that could trigger FDA corrective action requirements.