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Harbor Designs and Manufacturing, LLC1100 Wicomico St, Suite 600, Baltimore MD, 21230

 

Frequently asked questions

  • We provide customized services that include research and design, contract manufacturing, product development, packaging design, quality assurance, and more. Explore the full range of our services here.

  • We specialize in four core industries: Medical Devices, Consumer Products, Industrial Solutions and Rail & Transportation. See more about our industries here.

  • In addition to our contract manufacturing services, we also offer product design and other services to meet your unique needs.

  • We are ISO 9001 and ISO 13485 certified. What does that mean exactly? ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS). Implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.

    ISO 13485 is globally acknowledged as a standard for quality management systems tailored for medical device manufacturers. Aligned with the fundamental principles and clause structure of ISO 9001:2015, ISO 13485:2016 is commonly viewed as a vital initial measure to ensure the consistent production of high-quality products that adhere to regulatory standards in manufacturing and design processes. It serves as a tool to harmonize quality management systems with the regulatory requirements for medical devices in organizations engaged in various stages of the device's life cycle.

  • We ensure that before any project begins, both parties have mutually agreed upon and signed a Non-Disclosure Agreement (NDA). We are more than happy to review our NDA details with you to ensure you are well-informed and protected moving forward.