AdvancedCath is the leading source of advanced catheter systems. We deliver high quality, fast response, superior solutions and proactive service through our collaborative partnership approach.
At AdvancedCath, we’re ready to be your fast and flexible partner for the development of advanced catheter systems and components. Our experts work with your engineering team from new product development through commercialization. We have with a complete set of in-house technologies for catheter and guidewire manufacturing. We scale our production services to match your needs and grow with you from prototype, to pilot manufacturing, and high volume manufacturing with facilities located in the Boston, Minneapolis and San Jose in the United States and a manufacturing facility in a Costa Rica free trade zone.
Learn more about the history of AdvancedCath here.
At AdvancedCath, we strive to consistently provide value to our customers in the areas of quality, delivery and cost. Adherence to our quality management system, the requirements of our customers and regulatory authorities, enable us to achieve world-class medical device development and manufacturing.
Through our trained and experienced employees, AdvancedCath maintains a high level of quality assurance that includes quality control standards and production process controls. To ensure accuracy and precision, AdvancedCath manufactures products using on–line laser measuring devices and the latest technology in manufacturing and inspection equipment.
Learn more about our team of engineering professionals.
We firmly believe that our job is to listen and respond to our medical device OEM customer’s needs – whatever they are. However, when OEMs utilize all of the specialized expertise AdvancedCath has to offer – that’s when the relationship succeeds best. AdvancedCath is your partner in manufacturing. We work with our customers and are pleased to provide:
- 510(k) submission expertise
- Engineering design and development capabilities
- Complete on-site manufacturing – prototype to volume manufacturing
- Final product packaging & sterilization
- Inventory management
- Supply chain management
What’s more, when you choose to work with AdvancedCath, you’re assured 100 percent confidentiality. Our experienced engineering group will collaborate with our customers in the design and material selection phases of production to ensure the success of customer concepts. We can also design and develop tooling to meet our customers’ product requirements. Manufacturing to ISO 9001:2008 requirements also ensures our customers that they can rely on AdvancedCath for quality components from the first part to the last.
At AdvancedCath, we strive to consistently provide value to our customers in the areas of quality, delivery, and cost effectivity. Adherence to our quality management system, the requirements of our customers, and the regulatory authorities enables us to achieve world class medical device development and manufacturing status.
- EN ISO 13485:2012 and EN ISO 13485:2012/AC:2012 Certification
- ISO 13485:2003 CMDCAS Certification
- MDD Certification
- FMA Certification
- FDA registered
- Design control system compliant with FDA & European regulations
- Experience with the FDA 510(k) clearance process.
- Incoming/in-process inspection procedures
- Final release procedures
- Operational & manufacturing procedures
- Certificates of Compliance
- Device history records maintained to ensure GMP compliance.
Our four combined facilities have more than 90,000 square feet of manufacturing space including 30,000 square feet of class 100,000 ISO certified clean rooms. We have the ability to grow with your needs, multiple locations to serve you better and the expertise to assist you in all aspects of your products’ life cycle.
No matter what your needs, AdvancedCath is ready to assist you. Simply contact us for more information on how we can provide the products and services you need and we will be happy to help.