Anesthesia and Respiratory Device Expertise
MDCI works with respiratory and anesthesia device manufacturers to meet compliance and regulatory requirements to bring their products to market, including:
- Anesthesia systems and monitors, 510(k) premarket notification, software documentation
- Tracheostomy tube and accessories, 510(k) premarket notification, performance testing program development
- Autotransfusion devices
- Ventilators/resuscitators,
- Respiratory support products
Anesthesia & Respiratory Device Case study
An established medical device manufacturer developed a tracheostomy tube accessory that provided a unique locking connection between the tracheostomy tube and the respiratory circuit. During development of their 510(k) premarket notification, the company turned to MDCI to assist them with establishing appropriate performance specifications for the device and demonstrating compatibility with the tracheostomy tube with which the device was designed to connect.
Contact us today to learn more about our anesthesia and respiratory device expertise.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Client Testimonial
The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.
- International Trade Specialist at US Department of Commerce