MCRA’s leading experts are specialized in achieving success with international regulatory bodies. 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 regulatory agencies 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 international regulatory submissions. Our expertise extends to European, Australian, and Canadian markets, successfully remediating Technical Files and Clinical Evaluation Reports (EU CER) for compliance with MEDDEV 2.7.1. Rev. 4 for hundreds of medical devices across the industry.
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
International 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:
• Agency/Notified Body interaction
• Clinical testing plan
• Design dossier and technical file gap assessment
• Device classification
• Device listing
• Due diligence services
• Establishment registration
• European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR
• Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)
• Global regulatory strategy
• Import/export
• Labeling
• Medical device reporting
• Mock audits
• Notified body submission/Response
• Post-market surveillance
• Pre-clinical testing plan
• Quality system gap assessment
• Regulatory file letters
• Regulatory landscape assessment
• Training (EU MDR)