We are leaders in designing and remediating quality management systems under strict and changing standards. MCRA ensures compliance with ISO 13485, FDA Quality System Regulation, and other global QMS requirements, with special emphasis in establishing procedures for regulatory compliance tailored to your product line and target markets.
Contact a Cardiovascular Quality Assurance Expert
Cardiovascular Experience
MCRA offers unparalleled support to develop quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements to support development of cardiovascular devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for your devices all the way from device conception through release to market. Some key cardiovascular therapy areas of expertise include:
• 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
Quality Assurance Services
Our team offers setup of procedures for document control, R&D, risk management, software development, supplier evaluation, and control of measurement equipment, amongst others.
Our comprehensive quality assurance and manufacturing services include:
• Quality System Development
• Gap assessments
• Manufacturing and materials
• Mobile apps and software
• Mock inspections
• Perform internal quality system audits
• QA support
• Technical documentation and technical submissions