プロフィール詳細

プロジェクトを作成

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Dr. Jamila A.に依頼

France

MedTech Program Manager & SaMD Expert | FDA 510(k) · IVDR · IVD · Digital Health | 17+ Years

プロフィール概要

I help MedTech companies bring regulated products to market — from early development through regulatory submission — with a particular focus on SaMD, IVD devices, and digital health solutions. As co-founder and CTO of Brainreader A/S (Denmark), I led the full development and regulatory clearance of a CE-marked and FDA 510(k)-cleared neuroimaging SaMD — owning the product, the clinical evidence strategy, and the regulatory pathway end to end. More recently, I managed a point-of-care IVD project (qDOAC DISC) at Stago targeting both FDA 510(k) and IVDR submissions in an emergency diagnostics context. What I can do for your project: Regulatory strategy for IVDR, FDA 510(k), and IVD/SaMD submissions Cross-functional program management from concept to market Clinical evidence planning (CER, PMCF, usability, risk management) SaMD classification, IEC 62304, ISO 14971 alignment Bridging science, engineering, and regulatory in early-stage and scale-up teams I hold a PhD in Neuroimaging and a Master's in Bioinformatics, and I work fluently across English, French, and Danish environments. Available for focused advisory missions, regulatory gap assessments, and cross-functional program leadership.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Project Management

サービス

• Consulting
• Product Development

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC)

職務経験

Cross-Functional Project Manager

Stago (via Innovateam, consulting placement)

9月 2024 - 6月 2026

Clinical Product Manager

Visiopharm

4月 2022 - 5月 2024

Co-Founder CTO CSO

Brainreader

1月 2012 - 3月 2022

学歴

PhD | Neuroimaging

Aarhus University Hospital, Denmark

9月 2006 - 5月 2010

Msc. IT

Aarhus University, Denmark

9月 2003 - 7月 2005

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

(2020). Accuracy of MRI Classification Algorithms in a Tertiary Memory Center Clinical Routine Cohort. Arxiv.

(2020). Accuracy of MRI Classification Algorithms in a Tertiary Memory Center Clinical Routine Cohort . JOURNAL OF ALZHEIMERS DISEASE.

(2019). Machine Learning of Quantified Volumetric MR Imaging for Diagnostic Delineation of Alzheimer's Dementia and Mild Cognitive Impairment in the Alzheimer's Disease Neuroimaging Initiative. NEUROLOGY.

(2018). Application of Quantitative MR Imaging Volumetrics to a Combined Cognitive Neurology and Geropsychiatry Clinic Case Series. NEUROLOGY.

(2016). Quantitative Neuroimaging Software for Clinical Assessment of Hippocampal Volumes on MR Imaging . JOURNAL OF ALZHEIMERS DISEASE.

(2016). Reversal of cognitive decline in Alzheimer's disease . AGING-US.

(2013). Hippocampal volume and serotonin transporter polymorphism in major depressive disorder . ACTA NEUROPSYCHIATRICA.

(2012). Correlations between Stroop task performance and white matter lesion measures in late-onset major depression . PSYCHIATRY RESEARCH-NEUROIMAGING.

(2011). Longitudinal MR study of brain structure and hippocampus volume in major depressive disorder . ACTA PSYCHIATRICA SCANDINAVICA.

(2010). Depression severity is correlated to the integrity of white matter fiber tracts in late-onset major depression . PSYCHIATRY RESEARCH-NEUROIMAGING.

(2010). Hippocampal visuospatial function and volume in remitted depressed patients: An 8-year follow-up study . JOURNAL OF AFFECTIVE DISORDERS.

(2010). Localization of white-matter lesions and effect of vascular risk factors in late-onset major depression . PSYCHOLOGICAL MEDICINE.

(2010). Regional brain atrophy in primary fatigued patients with multiple sclerosis . NEUROIMAGE.

(2009). Regional brain atrophy involving the precentral gyrus is related to primary fatigue in multiple sclerosis. MULTIPLE SCLEROSIS.

(2008). Hippocampal volumetry and major depression - 7-year follow-up study. INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY.

(2008). Hippocampus related cognitive impairment in remitted depressed patients . JOURNAL OF AFFECTIVE DISORDERS.

(2008). White matter lesions and changes in cerebral microstructure in late-onset major depression. A diffusion tensor imaging study. INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY.