Cardiovascular Expertise You Can Trust

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Driving Regulatory Confidence and Lifecycle Integrity

Our Quality & Risk Management team brings deep expertise in safeguarding product safety, ensuring global regulatory compliance, and enabling continuous improvement throughout the medical device lifecycle. We are your strategic partner in building resilient systems that support innovation without compromising risk controls.

We specialize in rigorous, evidence-based risk analysis from design through post-market stages.

Our Capabilities Include:

• Design, Process, and Application FMEA (DFMEA, PFMEA, AFMEA)
• Risk Matrix development and real-time hazard analysis
• Product Risk Assessments (PRA) for both new and legacy devices
• Benefit-risk assessments to support regulatory submissions and change control 

Client Benefit:
✔ Reduced product failure risk
✔ Risk-informed design and post-market strategies
✔ Confidence in safety profile for regulators and clinicians

We manage the entire post-market risk continuum with transparency and efficiency.

We Provide:

• Adverse event tracking and trend analysis
• Root cause investigations and CAPA system implementation
• Field safety corrective actions and recall coordination
• Regulatory reporting and site communication 

Client Benefit:
✔ Minimized business disruption during adverse events
✔ Improved inspection readiness and reputation protection
✔ Strong alignment with GSPR, FDA QSR, and ISO 14971 standards

We support MDR/MDV readiness and global submissions with best-in-class documentation.

Deliverables Include:

• Summary of Safety and Clinical Performance (SSCP)
• Risk Management Files & Post-Market Surveillance Reports
• Safety data integration into technical files, DHFs, and CER 

Client Benefit:
✔ Streamlined regulatory approvals and technical audits
✔ Fully traceable documentation across the lifecycle
✔ Trusted partnership in regulatory submission strategy

 Let our experts help you embed quality, manage risk proactively, and support safe global delivery of your cardiovascular innovations. At Heart & Vascular Focus Advisory, we specialize in guiding cardiovascular practices towards success. Our team of experts provides high-level guidance and in-depth analysis that empowers healthcare providers to make informed decisions. Trust us to lead you on the path to excellence in patient care.