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At Amphenol Alden Products, Quality begins with a keen understanding of our customers’ needs and the role our cable assemblies play in their success. Using this insight we develop verification and validation criteria that help ensure product consistency and adherence to our customers’ performance requirements. Once a product achieves volume production, we relentlessly pursue continuous improvement and seek every opportunity to propose changes that will benefit the customer and their end-user. Our focus on continuous improvement extends into all areas of our business, from optimizing our business systems to diligent execution of Corrective Action / Preventative Action (CAPA) activities. We are always improving because we know lives depend on the devices we support.
Here are just some of the ways in which our medical interconnect manufacturing expertise brings value to your project:
Voice of Customer:
We systematically solicit and incorporate customer feedback throughout all phases of delivering superior products and exceptional service.
Risk Management:
Throughout the design and development cycle, tools such as Failure Mode Affect Analysis and Requirements Trace Matrix help us prevent problems before they occur.
Process Control:
Decades of experience in the medical market provide a deep knowledge and instinctual execution of IQ / OQ / PQ processes which ensure product consistency statistical-based process control.
Continuous Improvement Philosophy:
Six Sigma and Lean methods drive continuous improvement in all of our operations.
Sustainability to Supplier Management:
We are diligent and disciplined in our factories and do the same with our global suppliers.
Regulatory Certifications:
We maintain compliance to the following industry certifications
- FDA-registered facilities in Hermosillo, Mexico and Shenzhen, China
- ISO13485:2016 certified at all facilities
- ITAR compliant facility at our headquarters in Brockton, MA
- Environmental regulatory directives, including RoHS, REACH, and Conflict Minerals
ISO 13485 Certification
We are proud to maintain ISO 13485 certification, reflecting our commitment to quality management systems specific to the medical device industry. This certification ensures that our processes meet the highest standards for safety, reliability, and regulatory compliance. Please feel free to view and download our certification documentation.
