Board Certified, Cardiovascular & Thoracic Surgeon
Firas Alani, MD
Senior Clinical Assessor | EU MDR Expert | Medical Device Specialist
Bridging surgical expertise with regulatory science to ensure the safety and efficacy of innovative medical devices.
About
An accomplished Board Certified Cardiovascular & Thoracic Surgeon with over 25 years of experience spanning advanced cardiac surgery, global medical device vigilance, and regulatory affairs. Currently serving as Senior Clinical Assessor at DNV Life Sciences, providing expert clinical evaluation and assessment for CE marking under the EU Medical Device Regulation. Proven track record in leading cross-functional teams, managing certification decisions, ensuring audit readiness, and implementing risk-based quality and vigilance strategies to optimize device safety, efficacy, and lifecycle compliance.
Professional Experience
Over two decades of expertise across surgery, medical devices, and regulatory affairs
Senior Clinical Assessor
DNV - Life Sciences
Paris · Clinical Evaluation, EU MDR & Notified Body Activities
- Clinical assessment of Clinical Evaluation documentation in support of CE marking for medical devices.
- Assessment for clinical aspects of technical documentation across all medical device classes.
- Expert clinical recommendations to certification decision-makers.
- Evaluation of Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices.
Senior Clinical Assessor
DNV - Life Sciences
Paris · Clinical Evaluation, EU MDR & Notified Body Activities
- Clinical assessment of Clinical Evaluation documentation in support of CE marking for medical devices.
- Assessment for clinical aspects of technical documentation across all medical device classes.
- Expert clinical recommendations to certification decision-makers.
- Evaluation of Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices.
Head of Global Vigilance Operations
Guerbet HQ
Paris · Medical Device Vigilance – Team Leadership
- Management and coordination of a global medical device vigilance team (vigilance managers, physicians and officers).
- Oversight of global medical device vigilance operations, ensuring regulatory and quality compliance.
- Supervision of post-market safety and vigilance documentation (PMS plans/reports, PSURs, trend reports, CERs).
- Contribution to product risk–benefit assessments throughout the product lifecycle.
Head of Global Vigilance Operations
Guerbet HQ
Paris · Medical Device Vigilance – Team Leadership
- Management and coordination of a global medical device vigilance team (vigilance managers, physicians and officers).
- Oversight of global medical device vigilance operations, ensuring regulatory and quality compliance.
- Supervision of post-market safety and vigilance documentation (PMS plans/reports, PSURs, trend reports, CERs).
- Contribution to product risk–benefit assessments throughout the product lifecycle.
Field Clinical Procedure Specialist – Clinical Affairs EMEA
Abbott
Paris · EMEA Clinical Implementation, Training & Emerging Cardiac Technologies
- Provided clinical and technical field support for emerging Heart Failure and Cardiac Rhythm Management (CRM) technologies across the EMEA region.
- Management of heart failure patients using pulmonary artery pressure monitoring systems (CardioMEMS) and leadless pacemakers (Nanostim).
- Training programs and mentoring for investigators and site staff on device implantation and procedures.
- On-site follow-up support and troubleshooting, and relayed technical and clinical feedback to R&D teams.
Field Clinical Procedure Specialist – Clinical Affairs EMEA
Abbott
Paris · EMEA Clinical Implementation, Training & Emerging Cardiac Technologies
- Provided clinical and technical field support for emerging Heart Failure and Cardiac Rhythm Management (CRM) technologies across the EMEA region.
- Management of heart failure patients using pulmonary artery pressure monitoring systems (CardioMEMS) and leadless pacemakers (Nanostim).
- Training programs and mentoring for investigators and site staff on device implantation and procedures.
- On-site follow-up support and troubleshooting, and relayed technical and clinical feedback to R&D teams.
European Surgical Proctor
Bioventrix Inc.
Paris · Advanced Structural Heart Therapies
- Providing expertise in left ventricular reconstruction in post-myocardial infarction patients with left ventricular aneurysmal dyskinesia.
- Clinical support and procedural involvement in advanced structural heart therapies.
- Contribution to patient selection and procedural follow-up within multidisciplinary clinical teams.
European Surgical Proctor
Bioventrix Inc.
Paris · Advanced Structural Heart Therapies
- Providing expertise in left ventricular reconstruction in post-myocardial infarction patients with left ventricular aneurysmal dyskinesia.
- Clinical support and procedural involvement in advanced structural heart therapies.
- Contribution to patient selection and procedural follow-up within multidisciplinary clinical teams.
Expert Cardiovascular Surgeon – Clinical Reviewer (Class III Medical Devices)
TÜV SÜD
Munich · Global Medical Device Vigilance Leadership & Regulatory Oversight
- Clinical expertise for the assessment of high-risk Class III cardiovascular medical devices under EU MDR.
- Clinical evaluations of safety, performance and clinical benefit based on clinical investigations, post-market data and state-of-the-art analyses.
- Review and validation of Clinical Evaluation Reports (CER), risk–benefit analyses and post-market surveillance documentation.
- Providing expert clinical judgment supporting conformity assessments and certification decisions.
Expert Cardiovascular Surgeon – Clinical Reviewer (Class III Medical Devices)
TÜV SÜD
Munich · Global Medical Device Vigilance Leadership & Regulatory Oversight
- Clinical expertise for the assessment of high-risk Class III cardiovascular medical devices under EU MDR.
- Clinical evaluations of safety, performance and clinical benefit based on clinical investigations, post-market data and state-of-the-art analyses.
- Review and validation of Clinical Evaluation Reports (CER), risk–benefit analyses and post-market surveillance documentation.
- Providing expert clinical judgment supporting conformity assessments and certification decisions.
Manager, Product Safety – International Quality Affairs
Edwards Lifesciences
Paris · Global Product Safety & Medical Device Vigilance
- Global product safety oversight for heart valve prostheses and critical care devices across EMEAC, LATAM, APAC, GI, Japan and China.
- Medical investigations of product complaints, including health risk assessments, complaint data analysis and development of medical rationales.
- Medical Science Liaison, interfacing with clinical specialists, sales teams and healthcare professionals.
- Product Risk Assessments (PRA) and supporting CAPA activities.
Manager, Product Safety – International Quality Affairs
Edwards Lifesciences
Paris · Global Product Safety & Medical Device Vigilance
- Global product safety oversight for heart valve prostheses and critical care devices across EMEAC, LATAM, APAC, GI, Japan and China.
- Medical investigations of product complaints, including health risk assessments, complaint data analysis and development of medical rationales.
- Medical Science Liaison, interfacing with clinical specialists, sales teams and healthcare professionals.
- Product Risk Assessments (PRA) and supporting CAPA activities.
Manager Europe, Medical Affairs & Clinical Education
Plasma Surgical Ltd.
Paris · Medical Affairs Leadership & Clinical Education Strategy
- Medical Science Liaison (MSL) supporting the launch and adoption of an innovative plasma energy surgical tool across multiple surgical specialties.
- Developing and implementing training strategies and skill labs at key European centers of excellence (IRCAD Strasbourg, Amsterdam, Leuven, Rouen).
- Conducting medical investigations on product complaints, including health risk assessments and development of medical rationales.
- Supporting international product development and clinical research initiatives.
Manager Europe, Medical Affairs & Clinical Education
Plasma Surgical Ltd.
Paris · Medical Affairs Leadership & Clinical Education Strategy
- Medical Science Liaison (MSL) supporting the launch and adoption of an innovative plasma energy surgical tool across multiple surgical specialties.
- Developing and implementing training strategies and skill labs at key European centers of excellence (IRCAD Strasbourg, Amsterdam, Leuven, Rouen).
- Conducting medical investigations on product complaints, including health risk assessments and development of medical rationales.
- Supporting international product development and clinical research initiatives.
Specialist Cardiothoracic & Vascular Surgeon
Various Institutions
France & Middle East · Advanced Cardiac Surgery, ICU Management & Vascular Procedures
- Expertise in cardiac surgery focusing on valvular and congenital heart diseases, including advanced minimally invasive techniques such as mini-sternotomy and TAVI.
- Managed ICU for complex cardiac surgery patients.
- Performed cardiac transplantations, and managed intra-ventricular assist devices (LVAD) and pacemaker implantations.
- Experienced in general vascular surgical procedures across diverse clinical settings.
Specialist Cardiothoracic & Vascular Surgeon
Various Institutions
France & Middle East · Advanced Cardiac Surgery, ICU Management & Vascular Procedures
- Expertise in cardiac surgery focusing on valvular and congenital heart diseases, including advanced minimally invasive techniques such as mini-sternotomy and TAVI.
- Managed ICU for complex cardiac surgery patients.
- Performed cardiac transplantations, and managed intra-ventricular assist devices (LVAD) and pacemaker implantations.
- Experienced in general vascular surgical procedures across diverse clinical settings.
Program Medical Officer
International Committee of the Red Cross
Middle East · Missed Program – Data Management & Humanitarian Follow-Up
- Database management and ensuring accurate documentation of medical and administrative records.
- Monitoring and follow-up of missed persons files to support continuity of care in humanitarian settings.
- Collaboration with field teams to maintain data quality and support program reporting.
Program Medical Officer
International Committee of the Red Cross
Middle East · Missed Program – Data Management & Humanitarian Follow-Up
- Database management and ensuring accurate documentation of medical and administrative records.
- Monitoring and follow-up of missed persons files to support continuity of care in humanitarian settings.
- Collaboration with field teams to maintain data quality and support program reporting.
Education
Cardiac Surgery & Endovascular Management for Valve Diseases
Paris Descartes University
Paris
2009 – 2011
Board Certificate, Cardiovascular & Thoracic Surgery
IBMS
Iraq
1999 – 2005
MB, Ch.B (Bachelor of Medicine & Surgery)
Faculty of Medicine – Baghdad
Baghdad
1991 – 1997
Core Competencies
A unique combination of clinical expertise and regulatory knowledge
Clinical & Regulatory
Leadership & Management
Languages
Training & Certifications
Continuous professional development in regulatory and clinical assessment
TÜV SÜD
- Medical Reviewing: Directives 93/42/EEC as amended by 2007/47/EC
- MEDDEV 2.7/1 rev 3, MEDDEV 2.7/1 rev 4 and MEDDEV 2.12/2 rev 2
- ISO 14155 and ISO 14971
- ISO 13485
- ISO 13485 – Validation of Processes
- ISO 14971 – Risk Management
- Medical Device Development & Launch Guideline
IFIS Group
- Pharmacovigilance: Role, Missions and Responsibilities
DNV
- MDR Training for Medical Assessors
Awards & Recognition
EMEA Heart Award
Edwards Lifesciences
Recognition for outstanding achievements in Productivity, Quality or Compliance in the EMEA region.
First Commercial Implant Achievement
Abbott
Recognition for the successful first commercial implant of the CardioMEMS pulmonary artery pressure monitoring system.
Get In Touch
Interested in collaboration, regulatory consulting, or clinical assessment expertise? Let's connect.
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