The medical device industry represents a dynamic and critical sector of healthcare. Medical device technology advancements crucially enhance patient outcomes and actively transform the delivery of healthcare. By increasing high-quality medical device products at a rapid rate, hospitals can keep up with demand making healthcare more effective and efficient for both patients and healthcare providers. At Marquardt, we believe that when medical device customers and manufacturers collaborate, it enhances the quality of technology in the industry.
Globally, Marquardt has thousands of partners with whom we interact daily. We understand what it takes to work together for the future, benefiting both parties and providing long-lasting relationships and quality products to the end consumer.
Our US facility is ISO 13485:2016 certified, which is essential for medical device manufacturing. Being ISO 13485:2016 certified ensures regulatory compliance, product safety, quality improvement, and access to international markets. In addition to our ISO 13485:2016 certification, we offer several others that may suit your company’s needs:
- ISO 9001:2015 serves as an internationally recognized standard for quality management systems (QMS), offering organizations a framework to establish, implement, maintain, and continually enhance their QMS.
- ISO 14001:2015 stands as a globally acknowledged standard for environmental management systems (EMS). This certification is provided to companies that have a well-developed EMS.
- AS9100D is essential for organizations operating in the aerospace and defense industries focusing on quality management, safety, and process efficiency.
- IATF 16949:2016 is globally recognized quality management standard for the automotive industry – emphasizing the importance of QMS delivering high-quality products with continuous improvement and customer satisfaction.
- ITAR Compliance deals with the control of exporting and importing activities related to defense articles, technical data, and defense services.
Evidence from the Automotive Industry
Our history and growth demonstrate that we have what it takes to meet both customer and consumer demand. Crises can occur in any industry, and when it does you are going to want a manufacturer that can pivot, recover and execute when needed with experience working with large original equipment manufacturers (OEM). This is apparent in our automotive experience – a sector for which we are widely recognized both globally and locally. The demand for vehicles fluctuates, and it is our responsibility not only to meet these high demands, but also to maintain the trust that our products will exceed consumer expectations. We maintain strong relationships with our automotive customers, ensuring that when they request high-demand products, we consistently deliver the same reliable, high-quality solutions.
Medical Industry Experience
We also have experience in the medical device industry. During the COVID-19 pandemic, we produced connectors for ventilators and switches for local hospitals. Globally, we manufactured medical face masks for hospitals and consumers. Our experience in electronic devices led us to believe that we can provide locally manufactured medical devices that are high quality and affordable to the end consumer.
By partnering with us, you would have access to a global supply network with local response times tailored to suit your company’s needs. Contact us to learn more.