Dublin, April 14, 2026 (GLOBE NEWSWIRE) -- The "Regulatory Compliance and Safety Standards for Aesthetic Devices (June 12, 2026)" training has been added to ResearchAndMarkets.com's offering.
Medical devices with no medical purpose, commonly referred to as aesthetic devices, present unique regulatory challenges for the cosmetic industry.
While these devices do not treat or diagnose medical conditions, they must meet rigorous safety and efficacy standards, often comparable to those for medical devices (e.g., liposuction devices, dermal fillers). As such, aesthetic devices often exist in a regulatory grey area, as they serve non-therapeutic purposes. This ambiguity makes determining their classification - whether as medical devices or consumer products - complex.
The field of aesthetic devices is governed by stringent regulatory compliance and safety standards to ensure consumer safety and product efficacy. This involves adherence to global and regional regulations, such as FDA guidelines in the United States or CE marking requirements in Europe. Manufacturers must follow rigorous processes, including risk assessment, clinical evaluation, and quality management system (e.g., ISO 13485). Regulatory compliance not only mitigates risks but also fosters trust and credibility in the marketplace. Therefore, staying updated on regulations and safety standards is essential for professionals developing and working with aesthetic devices.
Unlock the knowledge and skills to navigate the complex regulatory landscape of aesthetic devices with confidence. This course is designed to empower professionals in the cosmetic industry to excel in global markets by understanding and addressing compliance challenges.
This comprehensive course explores the unique regulatory landscape for medical devices with no medical purpose, commonly known as aesthetic devices. Designed for cosmetic industry professionals, it provides an in-depth understanding of compliance challenges, safety standards, borderline definitions in aesthetics devices, and marketing strategies to ensure successful product development and market entry.
Dive into the intricacies of device classification under frameworks like the EU Medical Device Regulation (MDR 2017/745), ensuring you're equipped to meet regulatory requirements with ease. Learn how to demonstrate safety and efficacy for devices with subjective benefits using robust scientific evidence and gain the tools to craft marketing strategies that align with global standards while avoiding misleading claims.
Enhance your expertise in maintaining product safety through advanced post-market surveillance systems and effective adverse event monitoring. Explore how to navigate diverse international regulations, with insights into key regional differences, including the EU and U.S.A., to ensure seamless global compliance. Finally, discover best practices for fostering consumer trust through clear communication, and ethical transparency.
By the end of this course, you'll have the confidence to bring innovative aesthetic devices to market while maintaining the highest standards of safety, compliance, and credibility.
Participants will be equipped with the knowledge and tools to effectively manage the regulatory, safety, and ethical complexities of aesthetic devices, ensuring compliance and success in the global cosmetic industry.
Who Should Attend:
This training is suitable for any professionals involved with aesthetic devices, including:
- Regulatory Affairs Professionals
- Product Development Teams
- Clinical Affairs Specialists
- Quality Assurance Managers
- Cosmetic Industry Professionals
- Healthcare and Aesthetic Practitioners
- Academic and Research Professionals
- Entrepreneurs and Startups
Key Topics Covered:
- Device classification and regulation
- Safety and performance standards
- Global regulatory variability, marketing and claims management
- Ethical and consumer transparency
- Post-market vigilance and surveillance
CPD Hours: 4
Speakers
Catarina Carrao
Catarina Carrao is the founder of BioSciPons, a life sciences research organisation specialising in health technologies clinical development, evaluation and assessment, with expertise in AI/ML-enabled technologies. She co-ordinates expert teams to bridge the gap between innovation and regulatory compliance, helping developers navigate complex requirements while meeting the expectations of Notified Bodies and the FDA.
Catarina's academic background includes a Marie-Curie Fellowship at Charite Berlin, and Postdoctoral Fellowship at Yale's University Cardiovascular Research Center. She is a Fellow of the American Heart Association (FAHA) since 2013, Delegate of the European Society of Cardiology (ESC), and Professional member of the Health Technology Assessment International (HTAi) organization. She is an expert for the European Commission HaDEA on clinical investigations and Digital Health Technologies, and for the European Innovation and Technology (EIT) Council Health Cluster.
She has presented at RAPS Euroconvergence, the ESC Digital & AI Summit, and DIA Europe on AI/ML medical device regulation, post-market monitoring, and reimbursement pathways. Her recent publications include book chapters and articles on machine learning best practices, AI trustworthiness, and EU MDR/IVDR clinical evaluation.
For more information about this training visit https://www.researchandmarkets.com/r/3nffjx
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