Azza Gramoun
Mar 12
Digital tools for the clinical evaluation of medical devices
This article explores a selection of tools designed for device-related regulatory activities.
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Medical Reporting & Analytics
Welcome to Azante
Welcome to Azante Medical Reporting & Analytics, your trusted partner for top-tier medical regulatory writing and scientific communication. Founded by Dr. Azza Gramoun, Azante specializes in providing professional medical and scientific writing services bespoke to the medical device regulatory domain.
Our comprehensive services encompass regulatory strategy development, clinical data analysis, and documentation compilation for CE marking, including Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) plans, State of the Art (SOTA) literature reviews, and Systematic Literature Reviews (SLRs). As clinical data experts, Azante excels in creating customized strategies to maximize the potential of your data, ensuring regulatory compliance and optimal outcomes. Azante Medical Reporting & Analytics, a technology enthusiast, leverages advanced digital solutions to enhance efficiency and accuracy and ensure client satisfaction at every step of our collaboration.
Contact me today to discuss how Azante can support your medical writing and regulatory consulting needs.
Transforming Data into Regulatory Precision
SERVICES
Regulatory Writing and Consulting
Honing an extensive medical writing and regulatory writing skillsets, Azante provides expert writing services in:
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Clinical Evaluation: Comprehensive support for Clinical Evaluation Plan (CEP) and Report (CER), State of the Art (SOTA), Literature Search Review Plan (LSRP) and Report (LSRR).
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Clinical Evaluation: Comprehensive support for Clinical Evaluation Plan (CEP) and Report (CER), State of the Art (SOTA), Literature Search Review Plan (LSRP) and Report (LSRR).
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Clinical Development: Crafting Clinical Investigation Plan (CIP) and Report (CIR), Investigator’s Brochure (IB), and Synopses.
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Post-Market Clinical Follow-up: Assistance with PMCF plans and reports.
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Patient and Healthcare Professional Documents: Creation of Summary of Safety and Clinical Performance (SSCP), narratives, and Instructions for Use (IFU).
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Technical Documentation: Compilation of comprehensive technical documents.
Regulatory Writing and Consulting
Scientific Communication
With 15+ years of scientific writing experience, we can tackle projects of all scales:
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Publication Planning: Strategic plan development and management.
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Publication Planning: Strategic plan development and management.
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Manuscript Preparation: Drafting primary and secondary manuscripts.
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Journal Review Revision: Thorough review and revision for submission.
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Abstracts, Posters, Presentations: Creation of impactful materials.
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Structural Editing, Quality Control: Detailed quality assurance.
Scientific Communication
Technical
Writing
Our technical writing services include:
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User Manuals and Guides: Clear documentation for product usage.
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User Manuals and Guides: Clear documentation for product usage.
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Technical Specifications: Detailed descriptions of product features.
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Standard Operating Procedures (SOPs): Development of standardized procedures.
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User Manuals and Guides: Clear documentation for product usage.
Technical Writing
Scientific Copy Creation and Editing
Our expertise in scientific copywriting and editing extends to:
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Copy Creation: Crafting engaging scientific content.
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Copy Editing: Thorough editing for clarity and coherence.
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Copy Creation: Crafting engaging scientific content.
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Copy Editing: Thorough editing for clarity and coherence.
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Content Optimization: Fine-tuning for enhanced readability and impact.
Structural Editing & Quality Control
Alongside our editing and quality assurance services, we offer:
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Thorough Reviews: Ensuring accuracy, clarity, and consistency.
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Standardized Style: Implementing consistent formatting and citations.
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Thorough Reviews: Ensuring accuracy, clarity, and consistency.
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Standardized Style: Implementing consistent formatting and citations.
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Language Refinement: Enhancing readability and coherence.
CAREER PATH
Undergraduate Studies
Bachelor of Oral and Dental Medicine (Grande distinction with honours), Cairo University
Graduate Studies
Doctorate of Philosophy in Molecular Bone Biology, University of Toronto
Clinical Research Coordinator
Developing a study protocol for chair-side testing of antimicrobial resistance, DAAD
Postdoctoral Fellow
Monitoring arthritis using Nanoparticles as MRI contrast agent, University of Geneva
Lead Medical Writer
Conducting SLRs and clinical evaluations for medical devices, Giotto.ai
CERTIFICATIONS & PROFESSIONAL DEVELOPMENT
November 2023
Certificate
BSI Clinical evaluation for medical devices training and exam certificate
Workshops
May 2022- Present
EMWA Professional Development Program (EPDP)
1. Writing the State of the Art for Medical Devices according to MDR 2017/745
2. Writing a Clinical Evaluation Plan for Medical Devices
3. Post-market Clinical Follow-up (PMCF) for Medical Devices
4. Writing Clinical Evaluation Report for Medical Devices
5. Literature Reviews for Medical Devices
6. How to Compile the Summary of Safety and Clinical Performance (SSCP) for Medical Devices
7. Critical Appraisal of Medical Literature
8. Statistical Testing
9. Introduction to Pharmacovigilance Writing
November 2021
Workshops
Gathering Clinical Evidence for Medical Devices Training Educo Life Sciences, (3x 3-hour workshops)
4-month full-time program Pharmaakademie, Germany
Clinical Research Certificate
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Development and licensing of pharmaceutical products and medical devices
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Clinical trial overview (phases, design, protocol, monitoring and essential documents) as well as data management in clinical research (CTMS, EDC)
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Pharmacovigilance in drug/device development (AE, SAE, SUSAR)
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Human subject protection and regulatory oversight (AMG, MPG, ICH-GCP, EU MDR)
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Audits & inspections: ensuring clinical research quality
October 2020-Feb 2021
January 2016-June 2020
Certificate
Volkshochschule Bonn, Germany
Completed (B1) and (B2) level German certificates (Certificates obtained in June 2017 and 2020)
EXPERTISE
Oral and Dental Medicine
Molecular Cell Biology
Dental Implants
Orthopedics
(Knee and Hip Replacement)
Spinal Cord Stimulation
(SCS)
Clear Aligners
Arthritic Bone Diseases
Advanced Diagnostic Imaging Modalities (MRI and CT)
Health Technology Assessment (HTA)
Biomakers and In vitro Assays
Medical Reporting & Analytics
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