About Us

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 Our Medical Affairs team provides comprehensive scientific leadership and strategic support across the full continuum of cardiovascular innovation—from early-stage startups to established MedTech leaders. With deep expertise in medical oversight, clinical evidence generation, data interpretation, and dissemination for product approval and market adoption. 

Scientific Communications: Our team conducts in-depth literature reviews, evidence generation, gathers competitive intelligence, and prepares scientific materials for podium presentations, peer-reviewed manuscripts (ICJME-compliant), and regulatory communications. 

Key Opinion Leader Management: We manage all aspects of KOL engagement, including facilitating medical advisory boards, conference coverage, webinars, lunchtime symposia, and satellite meetings to ensure alignment with clinical realities and unmet needs. 

Professional Education: Our educational capabilities include sales force effectiveness, commercial excellence, hands-on training, small & large group workshops, and wet lab sessions, supporting both internal teams and external clinicians. 

Post-approval and Post-market Clinical Follow-up studies & Real World Evidence (RWE): We have extensive experience in overseeing investigator-sponsored studies (ISS), conducting post-market safety surveillance, evaluating adverse events, and performing data-driven, result-oriented benefit-risk analysis for regulatory compliance and market access. This involves utilizing Global Health Economics & Outcome Research and Global Access and Value Evaluation alongside RWE data.

Medical Information Management: We manage compliant, timely responses to medical information requests—including on-label and off-label inquiries—through validated systems, site visits, and one-on-one discussions with clinicians.

This team plays a crucial role as the trusted clinical-scientific partner that ensures therapies are safe and effective and understood, adopted, and embraced by the cardiovascular community.  

 Clinical Trials: Provide strategic medical and scientific expertise to support the design, initiation, execution, completion, and interpretation of clinical studies. 

Develop comprehensive clinical research strategies across all phases, including preclinical and Phase I-IV. Evaluate data for safety and efficacy, engage with regulatory agencies, and review and approve clinical study reports.

Direct and implement targeted strategies for study design, clinical trial protocol development, inclusion/exclusion criteria, electronic Case Report Forms (eCRFs), monitoring and execution of clinical trials, interpreting and reporting trial results, conducting edit checks, managing Clinical Study Databases, preparing informed consent forms, and overseeing trial master files.

FDA: Experience with FDA-related documents includes FDA-IDE protocols, Clinical Study Reports (CSRs), the PMA Module for clinical/medical documentation, and Summaries of Safety and Effectiveness Documents (SSED). 

EUMDR:  Experience in evaluating Clinical Evaluation Reports for EUMDR certification. This includes drafting and reviewing Clinical Investigation Plans (CIPs), Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), PMCF Plans, PMCF Evaluation Reports, post-market and post-approval clinical evidence generation, Clinical Investigation Reports, and Summaries of Safety and Clinical Performance (SSCPs), which are mandatory for Class III devices and implantables.

Clinical Trial Compliance: Monitor compliance with study protocols, FDA regulations, Good Clinical Practice (GCP), global regulatory standards, and internal policies. Review monitoring reports, protocol deviations, and trial metrics to ensure proper execution.

Approve the Clinical Study Report in collaboration with the Global Clinical Head (GCH), which includes preparing and producing sections such as Introduction, Results, and Discussion.

Medical Oversight and Safety Reviews: Provide medical and trial oversight for the Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) to ensure timely adjudication of adverse events for safety and data monitoring. Lead medical safety teams in analyzing adverse events and conducting periodic safety review meetings. Regularly hold safety review boards, monitor serious adverse event (SAE) trends, and perform benefit-risk assessments.

Physician Education and Communication: Maintain strong communication with investigators, focusing on study rationale, clarity regarding inclusion/exclusion criteria, and precision in follow-up procedures. 

 Assist in preparing product brochures, patient brochures,  animation and procedural videos, product training, customer feedback surveys, and instructions for use (IFU) documents while collaborating with  MedTech industry marketing teams.

Advertising and promotion (A&P) of medical devices is heavily regulated across different global markets to ensure truthful, non-misleading claims, regulatory compliance, and ethical marketing.

Each regulatory agency enforces different rules on claims, clinical evidence, direct-to-consumer (DTC) advertising, and promotional material approvals. For example;

 EU MDR: Ensure all claims align with CERs & PMCF data to withstand Notified Body audits.

 India MDR 2017: Obtain CDSCO ad pre-approval for Class C/D devices before market launch.
Japan PMDA: Submit all advertising materials for PMDA approval before use.
China NMPA: Use locally approved clinical trial data for advertisements.
Australia TGA: Follow the Advertising Code (Therapeutic Goods Act 1989) to avoid fines.
Korea MFDS: Submit marketing claims for MFDS pre-approval before launching promotions. 

 Our team is an exceptional, multidisciplinary research and development engineering group committed to pioneering the next generation of cardiovascular therapies for Structural Heart disease, coronary artery disease,  and heart failure management. 

Our elite group excels across the entire innovation continuum—from clinical needs assessment and ideation to concept screening, rapid prototyping, and seamless handover to product development. With deep subject matter expertise, the team brings over 35 years of combined experience and a proven track record of successfully developing seven groundbreaking cardiovascular products in the last five years.

Their specialized capabilities encompass advanced device design, material selection for durability-critical components, and rigorous mechanical verification, including stress, fatigue, and functional testing aligned with ISO and regulatory standards. 

This team serves as a cornerstone in delivering transformative, patient-centric solutions that redefine the future of cardiovascular care.  They are dedicated to advancing the development of innovative medical products that empower clinicians to improve patient outcomes and provide an exceptional return on investment.

 Our Quality & Risk Management team comprises highly skilled and experienced quality engineers dedicated to ensuring product safety, regulatory compliance, and continuous improvement throughout the product lifecycle. 

With deep expertise in risk-based design and post-market surveillance, the team delivers comprehensive failure mode analysis through AFMEA, DFMEA, PFMEA, and Risk Matrix methodologies while proactively identifying and mitigating hazards and harms. They lead adverse event trending, implement robust CAPA systems, and conduct objective benefit-risk analyses to support both premarket and post-market decision-making. 

The team excels in product risk assessments (PRA), manages field corrective actions, and navigates product recalls with timely, transparent, and compliant communications to clinical sites and regulatory authorities. 

Our team's  Mastery in MDR/MDV documentation, SSCP development, and global regulatory submissions positions them as essential partners in safely bringing innovative therapies to patients responsibly.  

 Our Regulatory Affairs team is a highly strategic and influential function. It leads critical medical and clinical discussions with global regulatory authorities throughout the product lifecycle. 

Collaborating closely with industry partners, the team actively participates in Q-Submissions, Pre-Sub meetings, protocol amendments, interim data reviews, and benefit-risk assessments, ensuring that every clinical strategy aligns with evolving regulatory expectations. 

With demonstrated expertise in drafting and reviewing the clinical and medical content of PMAs, 510(k)s, and clinical investigation reports, the team provides clear, compelling evidence packages that accelerate approvals and reduce regulatory risk. 

Our experts confidently lead from the front—bringing a seat at the table with regulatory agencies, and influencing decision-making through data-driven, patient-centric advocacy. The team maintains strong capabilities in global regulatory intelligence, continuously tracking policy changes, guidance updates, and market access trends through leading platforms. 

With over 25 years of combined experience in GMP compliance and regulatory audits, this group ensures that every submission is grounded in quality, strategy, and scientific integrity.