01 / Quality & Regulatory
Cordica supports regulated medical-device programs through ISO-certified quality systems, FDA-registered operations where applicable, controlled manufacturing environments, and quality expertise throughout development, production, and post-market surveillance.
02 / Quality Scope
Medical-device programs require product and process requirements to translate into controlled manufacturing methods that can be repeated throughout production.
The specific requirements, certifications, registrations/licenses, and controls depend on risk factors, facility, product, activity, and market involved.
Active scope / Quality Management
Quality system
Cordica Medical’s Quality Management System aligns with U.S. requirements and foreign equivalents where applicable, to ensure product safety and performance for the patients we serve.
Quality system
Cordica Medical’s quality infrastructure includes ISO 13485-certified quality management systems, supporting the design, manufacturing, and packaging of medical devices as well as combination products.
Scope: Certified Quality Management Systems
03 / Facility-Specific Scope
Certifications, registrations/licenses, cleanroom, and quality-system scope vary by facility and manufacturing activity. Contact Cordica to confirm the requirements applicable to a specific program.
Cordica’s Singapore operations are ISO 13485 & 9001-certified.
Explore Locations →
04 / Controlled Environments
Cordica’s manufacturing platform includes ISO Class 7 and ISO Class 8 cleanroom capabilities within applicable operations, as well as UV-, temperature-, and humidity-controlled environments where applicable.
Available within applicable Cordica operations and development programs.
Supports applicable manufacturing, molding, catheter, assembly, and other medical-device activities across parts of the Cordica platform.
Availability and classification vary by location and manufacturing process.
05 / Development + Manufacturing Quality
Depending on the program, quality and regulatory engineering can operate alongside product engineering, process development, inspection, testing, validation, and manufacturing preparation.
Use of vision and optical inspection systems where appropriate to verify product quality and monitor manufacturing processes.
Integrate device or assembly testing where the program requires functional confirmation during manufacturing.
Develop manufacturing controls to reduce variation and provide action limits around Critical to Quality (CTQ) attributes that are most important to maintaining consistent product quality.
Integrate inspection and process control into automated manufacturing processes, where the program supports it.
Regulatory Engineering
Quality Engineering
Test method development and validation
Design verification & validation
Design for Manufacturability (DFM)
Clinical trial design and execution support
Animal lab planning and management
Cadaver lab planning and management
Quality + Program Support
