Anesthesia and Respiratory Device Expertise
Aptiv Solutions works with respiratory and anesthesia medical 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
- Extracorporeal membrane ventilator – FDA pre-IDE, IDE support, clinical study protocol development, labeling reviews
- CPR assist devices / resuscitators – FDA regulatory guidance, labeling review, document submission and registration
- Oxygen delivery / flowmeter device – FDA compliance assistance, warning letter response
- Automated closed loop ventilation system – FDA regulatory strategy, pre-IDE activities, software documentation review, labeling review
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 our expert regulatory staff 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.
