Our Experience in Anesthesia, Respiratory, Sleep, & ENT Devices
Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help our clients achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory and commercial landscape to align with the FDA's focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development. The battery of services in the MCRA Anesthesia, Respiratory, Sleep, & ENT portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and FDA approval of anesthesia, respiratory, sleep, & ENT devices, to widespread market use and payor reimbursement. As stewards of technologies intended to treat patients in the anesthesia or critical care space, as well as those with respiratory conditions, MCRA Anesthesia, Respiratory, Sleep, & ENT is woven into the fabric of what we do and fuels our passion to bring the most advanced medical devices and therapies to those in need.
MCRA Anesthesia has decades of combined experience with critical care and anesthesia devices. We also have direct oversight from multiple former FDA personnel in Anesthesia, Respiratory, Sleep, & ENT devices. Our organization is capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:
- Abnormal Breathing Sound Devices
- Airway Monitoring Systems
- Anesthesia catheters, filters, and needles
- Anesthesia gas and oxygen masks
- Anesthesia gas machines and vaporizers
- Anesthesia pain monitors
- Apnea monitors
- Breathing Frequency Monitor
- Breathing Gases Mixer
- Carbon dioxide absorber and anesthetic gas scavengers
- CPAP and BiPAP devices
- Cricothyrotomy devices
- Dental Protectors
- Depth of anesthesia monitors
- Endotracheal, endobronchial, and tracheostomy tubes and stylets
- End-tidal CO2 monitors and masks
- Epidural catheters, needles, and delivery devices
- Gas Analyzers
- High flow oxygen delivery devices
- Humidifier and masks
- Hyperbaric chambers
- Infant baby monitors
- Nerve stimulators
- Nitric oxide delivery and generating devices
- Opioid use disorder devices
- Oral and nasal airways
- Oxygen concentrators
- Oxygen conservers
- Oxygen tents
- Peripheral nerve blocks
- Portable air compressor
- Pulmonary function calculators
- Pulse oximeters
- Topical Anesthesia Applicator
- Tracheobronchial suction catheters
- Ultrasound guided nerve blocks
- Ventilatory Effort Recorder
We are proud of the industry expertise and scientific know-how our team brings to the table. They are the reason we are able to provide our clients with what they need to bring their devices to market as successfully as possible. Meet our talented team of experts in this field below.
Todd Courtney, M.S., CQIA
Anesthesia, Respiratory, Sleep, & ENT Medical Devices Services
Anesthesia and Critical Care Medical Devices Clinical Research Organization (CRO)
Our clients count on our proven expertise, world-class facilities, and dedicated team of professionals to provide them with the support they need for their new technologies.
Anesthesia, Respiratory, Sleep, & ENT Medical Devices US Regulatory
Let us help shepherd your devices through the complex and often confusing FDA regulatory process to ensure the best results.
Anesthesia, Respiratory, Sleep, & ENT Medical Devices Global Regulatory
For those seeking to break into multiple markets around the world, we have the regulatory and scientific leadership needed to help accomplish their goals.
Anesthesia, Respiratory, Sleep, & ENT Medical Devices Reimbursement, Health Economics, and Market Access
With more than 50 years of experience regarding reimbursement, health economics, and public policy services, we can be your full-service resource for all of it.
Anesthesia, Respiratory, Sleep, & ENT Medical Devices Quality Assurance
We provide all the necessary expertise when it comes to managing document control, R&D, risk management, software development, supplier evaluation, measurement equipment control, and other processes.
Anesthesia, Respiratory, Sleep, & ENT Medical Devices Healthcare Compliance
We can take the wheel when you need help with complicated legal and regulatory obligations, no matter what you have to face.
Anesthesia, Respiratory, Sleep, & ENT Medical Devices Cybersecurity
Advanced technology with Internet connectivity must be secured against the threats of cybercrime and hacking, and that’s what we can deliver.