Quality & Regulatory Compliance
Quality is built into every stage of our manufacturing process, supported by an ISO 13485-certified quality management system, rigorous process controls, product verification, and regulatory compliance across key global markets.
ISO 13485 Certified
Quality Management System
Controlled Inspection
Product Verification & Testing
Global Compliance
Multiple Regulatory Markets
Global Quality & Regulatory Credentials
Selected certifications, registrations, and regulatory credentials supporting Goldstar products across key international markets.
ISO 13485 Certified
ISO 13485-certified Quality Management System supporting controlled design, manufacturing, inspection, documentation, and quality assurance.
CE Marked · EU MDR Compliance
Medical devices CE marked in accordance with applicable requirements of the European Medical Device Regulation (EU) 2017/745.
UKCA Marked · UK MDR Compliance
Medical devices UKCA marked in accordance with applicable requirements of the UK Medical Devices Regulations.
FDA REGISTRATION
Goldstar’s manufacturing establishment is registered with the U.S. FDA, with its medical devices listed with the FDA.
ANVISA Registered
Medical devices registered with ANVISA in accordance with applicable requirements for supply in the Brazilian market.
Saudi FDA Authorized
Medical devices registered with the Saudi Food and Drug Authority in accordance with applicable requirements for the Saudi market.
OUR QUALITY STANDARDS
Quality Built Into Every Stage
At Goldstar Medical Instruments, quality is integrated throughout our manufacturing processes. Our ISO 13485-certified Quality Management System provides documented controls across sourcing, production, inspection, validation, traceability, and continuous improvement.
- Supplier qualification and incoming material inspection
- In-process inspection and quality controls
- Final product inspection and verification
- Process and equipment validation
- Sterilization validation for applicable products
- Product identification and traceability
- Calibration and preventive maintenance programs
- Internal audits and management review
- Employee training and competency management
- CAPA and continuous improvement programs
Partner with Goldstar
Work with an experienced medical device manufacturer combining specialized manufacturing, rigorous quality controls, and regulatory expertise across global markets.