Medical component manufacturing of exceptional product quality demands meticulous attention to detail. That’s why Custom Wire Technologies partners closely with customers, taking the time to fully understand the functionality, application, and specific requirements of their end products. This collaborative approach allows CWT to streamline manufacturing processes and develop thorough inspection plans that ensure every product delivered reflects industry-leading excellence and meets the highest performance standards.
CWT sets the benchmark for world-class quality, guaranteeing that every product not only meets but exceeds the highest standards established by U.S. and international agencies. With cutting-edge precision testing technologies, CWT relentlessly optimizes its engineering and manufacturing processes, ensuring flawless execution and unmatched reliability.
Comprehensive Quality Management
Quality Assurance means building quality into every step of a device’s production process, while Quality Control focuses on testing product samples to ensure they meet strict specifications for consistent, high-quality results. Both are non-negotiable in medical device manufacturing, but how can companies ensure that externally sourced components, like medical wire for guidewires and catheters, meet the same rigorous standards? Let’s explore this critical aspect of maintaining excellence in medical device production.
Original equipment manufacturers (OEMs) often rely on custom-made medical wire solutions to meet precise specifications for length, diameter, and other critical parameters. As Dheeraj Verma, a quality technician at CWT, explains, factors like the physical dimensions, mechanical properties, and appearance of medical wire directly impact the fit, form, and function of the final product. This makes the quality of the wire a pivotal factor—not just for the performance of the medical device, but for the safety and well-being of the patients who depend on it.
“Failure to meet the quality requirements of a component or device could cause a failure in the intended application, affecting patient safety,” Verma describes. “At CWT, we take pride in manufacturing our highest quality products by following all customer requirements. We pay attention to every detail. Our experienced engineering and quality team determines specific manufacturing processes by following all quality requirements for product conformity.”
“We have multiple layers of inspection during our manufacturing process to assure we manufacture top-quality products. Quality inspection of all products is performed both during production and before shipping products to our customers,” states Verma. “In addition, the quality department performs daily audits on manufacturing process steps to assure that the correct manufacturing processes are being followed and customer requirements met.”
Also Read: Choosing a Medical Device Component Manufacturer To Fit Your Needs
Regulatory Compliance: Navigating Global Standards
Over the past 50 years, the medical device industry has seen incredible advancements, driven by the critical role of quality management systems and strict regulations. These frameworks have been the foundation for developing, manufacturing, and delivering the innovative technologies that ensure safe and effective healthcare worldwide.
As an ISO 13485-certified leader in custom wire components and assemblies, CWT prioritizes clear, open communication with its customers to fully understand the unique regulatory requirements of every product. This collaborative approach ensures compliance and precision at every step. According to Glenn Esselman, quality assurance manager at CWT, “The benefits of maintaining ISO certification and open communication means we are meeting the requirements of the products we produce, as well as gaining the confidence of our customers that we are a partner in their success.”
The ISO 13485:2016 Certification is a globally recognized certification signifying compliance with quality management system requirements specific to medical devices. CWT has been certified under certificate number C092518, with the current certification effective as of September 22, 2024, and valid until September 21, 2027. Verisys Registrars ensures the validity of this certification through regular assessments, reaffirming CWT’s commitment to maintaining the highest standards.
Regulations shape every phase of a medical device’s lifecycle, from initial development and validation to ongoing post-market surveillance. A pivotal moment in this process is the premarketing submission, where, in the U.S., companies must file a 510(k) application with the FDA. For companies looking to expand globally, securing clearance from the relevant health authorities in each target market is equally essential. These regulatory milestones ensure that medical devices meet the highest standards for safety and effectiveness, both at home and abroad.
“This is where matters can get complicated,” says Esselman. “It comes down to how each country deals with trying to mitigate the risk from issues that each has seen,” he states. “The impact can be challenging for many companies launching products in multiple markets. The resources needed to keep up and comply with the various regulations can be a difficult task.”
Bridging the Gaps in Changing Regulations
The medical device industry operates within a dynamic regulatory landscape, with variations across jurisdictions and frequent updates to existing rules. This creates a challenging environment for international companies to navigate, often leading to gaps in understanding and compliance.
“Due to the ever-changing needs and the new advancements of technology in the medical industry, there will always be gaps and the need for changes in regulations,” says Esselman. “Most of the time, a difference in the interpretation of a requirement creates holes or gaps. Truly understanding the correct meaning or intent of the regulation is key.”
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Custom Wire Technologies is here to serve your business with unparalleled expertise in custom wire components, including coils, wire forms, core wires, and custom guidewire assemblies. Contact us today to learn how we can support your project and deliver exceptional results.
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