ISO 13458: Medical Quality Management
What Is ISO 13485?
ISO 13485 is the internationally recognized standard for quality management systems specific to medical device manufacturing. It ensures consistent quality and safety in medical device production by focusing on:
- Risk management and design control throughout the product lifecycle.
- Comprehensive documentation and process validation.
- Ongoing quality monitoring and continuous improvement of processes.
This rigorous standard is designed to meet the unique regulatory requirements of the medical device industry, providing assurance to manufacturers, healthcare professionals, and patients.
Halco’s Commitment to ISO 13485 Certification
At Halco, we take pride in maintaining ISO 13485 certification across our medical device component manufacturing operations. This certification reflects our dedication to delivering high-quality, reliable solutions for the medical industry. Our quality management system includes:
- Specialized documentation and tracking procedures to maintain compliance.
- Controlled environments designed to preserve the integrity of medical-grade materials.
- Stringent process controls to ensure the consistency, safety, and reliability of every component we produce.
By adhering to these standards, Halco serves as a trusted partner for medical device manufacturers worldwide, delivering innovative solutions that meet and exceed industry expectations.
Contact us today to discuss your project, request samples, or explore how Halco can support your quality and compliance needs.