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Publications
- Early Meeting with HAS: Medical Device companies should You Request it?
- Medical Devices and Materiovigilance: Are You Aware of the 2025 Requirements?
- Artificial Intelligence (AI) and Clinical Research: A Quiet Revolution with Spectacular Results
- Publishing Clinical Trial Results: A Regulatory Obstacle or Strategic Opportunity?
- Pharmacovigilance 2.0: How AI Is Revolutionizing Patient Safety Today
- IA Act: New Constraints or a Competitive Advantage for Clinical Research?
- Publishing a Clinical Trial: When and Why It Becomes Essential
- MDR Regulation: Framework and Challenges
- Literature review: mastering the art of impactful scientific writing
- European regulation 536/2014: the basics you need to know
- Open access to clinical trial results: a public health imperative?
- Choose a journal to publish a scientific article: the ultimate guide
- Generative AI and clinical trials: a game-changer for medical research
- Self-Assembling Peptides: An Emerging Lever for Surgery and Wound Healing
- Revised CTIS: a strategic change not to ignore
- Submitting a Scientific Article: Common Mistakes to Avoid Submitting a Scientific Article
- How to choose the right primary criteria in a clinical trial: the key to scientific, regulatory and economic success
- Self-assembling peptides: a new generation of medical devices for surgical haemostasis
- Digital health technologies and clinical trials: the strategic shift the industry can no longer ignore
- Digital medical devices: Europe facing the urgency of a harmonized framework
- Clinical trials: accelerating drug and medical device innovation to remain competitive
- Evaluation of digital medical devices: HAS clarifies its expectations
- Clinical evaluation of digital medical devices and LATM: regulatory and clinical requirements
- PECAN fast-track pathway: evaluating digital medical devices
- Clinical development of digital medical devices: practical benchmarks from the HAS
- CE marking of medical devices: exploding delays threatening innovation in Europe
- Orphan medical devices: the forgotten victims of MDR and IVDR
- High-risk medical devices: a crucial challenge at the crossroads of AI and European certification
- AI Act and medical devices: integrating clinical and regulatory compliance strategically
- CE marking of medical devices: a critical clinical and regulatory milestone
- Clinical evaluation of medical devices: anticipating CE marking and market access in France
- CE marking and reimbursement: 2024 marks a turning point for clinical rigor in Europe
- Sustainability of medical devices: what impact on clinical evaluation?
- Data privacy in clinical trials for medical devices: a major compliance challenge
- Data protection in clinical trials for medical devices: understanding CNIL’s role and best practices
- Post-market surveillance and vigilance for medical devices: anticipating feedback and ensuring compliance
- Clinical investigation transparency: a strategic imperative for medical devices
- Medical device geopolitics: risks and opportunities for Europe’s supply chain
- Artificial intelligence in clinical research: opportunities, limitations, and industry transformation
- Patient-centricity in medical device clinical trials: buzzword or real shift?
- Health literacy: the hidden key to safer clinical research and better medical device use
- CNIL consultation and medical devices: what changes for health research
- EUDAMED becomes mandatory: what changes with the European Commission decision of 26 November 2025
- Real-world data: what role do they play in clinical research today?
- Targeted revision of the MDR / IVDR: what the European Commission proposed in December 2025
- A new CE marking for medical devices: towards a simpler, more predictable system
- Sustainable development of medical devices: an unavoidable challenge for healthcare systems
- Fast-track clinical trials: a new acceleration of drug authorisations in France and Europe in 2026
- European Artificial Intelligence Act: ANSM and DGCCRF at the forefront of controlling high-risk medical devices
- Medical Affairs and patient-centricity: how the function is becoming a strategic driver of engagement
- Circular economy of medical devices: reconciling clinical performance, sustainability and regulatory requirements
- Real-World Data (RWD): towards a new clinical evidence paradigm for medicines and medical devices
- FAST-EU pilot for multinational clinical trials: accelerating clinical trial authorisation in the European Union
- European Biotech Act: a new strategic framework to accelerate innovation in medicines and medical devices
- Artificial intelligence for clinical research: a major lever to accelerate drug development
- Adaptive clinical trials: methodological promise or operational reality for medicines and medical devices?
- Corelabs and clinical investigations: a strategic lever for data quality
- Algorithmic bias in clinical research and AI-driven recruitment: an invisible risk?
- Big Data in Clinical Research: Opportunity or a New Layer of Complexity?
- Investigational Sites: The Critical Link in Accelerating Clinical Research
- Post-authorization studies: Regulatory Constraint or Strategic Lever for Medicines and Medical Devices?
- Drug vs Medical Device: Are Regulatory Boundaries Becoming Increasingly Blurred?
- Clinical Trials in Europe: EMA Publishes Guidance for Public Health Emergencies
- Clinical Investigations of Medical Devices: Why Demonstrating Clinical Benefit Remains More Complex Than for Medicines
- Clinical Trials: Is Spain Overtaking France?
- Cybersecurity of Connected Medical Devices: A Major Clinical Safety Issue
- Patient Registries and Medical Device Registries: An Underused Resource for Clinical Research?
- Indirect Treatment Comparisons: How Can Similarity Be Demonstrated Without Direct Clinical Trials?
- Shortage of medical devices: has the MDR weakened access to health technologies?
- FAST-EU: a new step toward the acceleration of clinical trials in Europe
- End of animal testing: AI and biotechnology are accelerating the transition
- Sham devices in clinical investigations: why simulated devices are becoming essential
- EUDAMED, regulatory update: the use of certain modules becomes mandatory from 2026
- Real-World Evidence for Medical Devices: How the FDA Is Transforming Approval
- CNIL and Clinical Research: What Are the Obligations for Health Data?
- EUDAMED Penalties: What Are the Risks of Non-Compliance Under the MDR?
- Regulation of Food Supplements: A Less Regulated Market in Europe? Really?
- RWE and HAS: Why Some Real-World Data Convince the HAS… and Others Do Not
- Low-Intervention Clinical Trials: An Underused Opportunity in Europe?
- EUDAMED: Complete Guide to the European Database on Medical Devices
- COVID-19 Vaccines: Which Procedures Were Really Accelerated in Europe?
- AI-Driven Drug Discovery: Towards a New Acceleration of Pharmaceutical Innovation?
- Clinical Trial Recruitment Challenges in Europe: Why Is Patient Enrollment Becoming More Difficult?
- European AI Compliance: Why the Regulatory Timeline May Already Change
- Fake Health Innovations: How to Distinguish Real Innovation from Marketing Hype
- Monitoring Visit: Anatomy of a Successful Day for a Clinical Research Associate
- Generative AI in medical writing: Revolution or danger zone?
- Decentralized Clinical Trials (DCT): What French Sponsors Still Hesitate to Do
- Clinical trials for biotechs: How Europe leverages FDA regulatory instability
- FAST-EU: The European Initiative That Could Transform Clinical Trials
- Economic Simplification Act: What Impact on Clinical Research in France?
- Developing an innovative medical device: Key steps from design to CE marking
- GDPR Applied to Clinical Trials: 2026 Compliance Checklist
- EU Legal Representative for Clinical Trials: Why It Is Essential
- Medical Device Vigilance in Clinical Trials: Obligations and Common Mistakes to Avoid
- Clinical trials & start-ups: Why CROs are essential
- Dietary supplements: regulatory obligations and the framework for human studies
- European new pharmaceutical legislation: what it means for laboratories and clinical research
- Patient Partners: From Digital Co-Design to Clinical Research, a Transformation to Watch Closely
- Artificial intelligence in clinical research: 7 real-world use cases already in practice
- From Idea to Protocol: 7 Key Steps in Clinical Trial Design
- Clinical research for medical devices: the silent transformation under the MDR
- ANSM, EMA, Ethics Committees: Who Does What in Clinical Trial Approval?
- GDPR and health data in clinical research: key points to watch
- Choosing a CRO for medical devices: 7 criteria sponsors overlook
- Clinical Research Training for Beginners: Where to Start?
- Self-Assembling Peptides in Biomedicine: State of the Art and Outlook
- Reimbursement of a Digital Therapeutic: HAS Opens a Historic First
