MCRA’s leading experts are specialized in achieving success with the US FDA. Our team has industry leading experience with global regulatory strategy and deep understanding of the device lifecycle assisting through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization, providing MCRA's clients with the best representation to the US FDA in demonstrating the science, safety, and efficacy of their technologies.
Contact a Cardiovascular Regulatory Expert
Cardiovascular Experience
MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class cardiovascular devices.
MCRA is a world-class provider of regulatory strategy and advice for cardiovascular devices, including:
• Ablation systems
• Angioplasty balloons
• Artificial hearts
• ASD & PFO occluders
• Atherectomy devices
• Automated external defibrillators (AED)
• Blood pressure monitors
• Cardiac diagnostics - imaging
• Cardiac electrophysiology
• Cardiac mapping technologies
• Circulatory support
• Compressible limb sleeves
• Counterpulsation pump devices
• Diagnostic catheters
• Drug-eluting stents
• ECMO devices
• Embolic devices
• Guidewires
• Heart failure devices
• Heart valves
• Hemodialysis access
• ICD and RCT therapy
• Implantable electrophysiology devices
• Interventional cardiology
• Leads
• Left atrial appendage occlusion devices
• Left ventricular assist devices (Adult & Pediatric LVAD)
• Mobile apps
• Orbital atherectomy systems
• Pacemakers
• Pericardial patches
• Peripheral vascular
• Renal denervation
• Rhythm management
• Structural heart
• Therapeutic lead EP & intravascular ultrasound
• Vascular closure devices and general vascular surgery devices
• Vascular grafts
• Vascular stents
• Ventricular assist devices
US Regulatory Services
MCRA has industry leading specialization in the full spectrum of cardiovascular medical devices, with strong regulatory and scientific leadership offering deep expertise in the complex cardiovascular space.
Our comprehensive regulatory services include:
• Global and US regulatory strategy
• Regulatory landscape assessment
• Gap analysis
• Investigational Device Exemption (IDE)
• De Novo
• 510(k)
• Premarket Approval (PMA)
• FDA appeals
• FDA training
• FDA warning letters and 483 observations
• Pre-clinical testing plan
• Clinical testing plan
• Due diligence services
• Agency interaction
• Device classification
• Import/export
• Labeling
• FDA meeting strategy
• Real-time reviews
• Device listing
• Establishment registration
• Regulatory file letters
• Medical device reporting
• IDE Reporting