Presented by
Management Forum
Navigate regulatory complexities and device classifications in the aesthetic medical device industry.
4 April 2025
+ 12 September 2025, 5 December 2025 »
from £649
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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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
This training is suitable for any professionals involved with aesthetic devices, including:
Catarina Carrão from BioSciPons, is a clinical evaluation and benefit-risk assessment specialist. Previously, she studied Biochemistry and worked in academic research. In 2006, she was a Marie-Curie Early Stage Researcher in the Universitätsmedizin Charité Berlin. In 2011, she was a Postdoctoral fellow at the University of Yale Cardiovascular Research Centre (YCRC). In 2012, she received the European Science Slam title. In 2013, she was awarded Fellow of the American Heart Association (FAHA). In 2021 she was nominated Young Science Journalist of the Year by the Association of British Science Writers (ABSW).
Her scientific expertise in neuroscience, cardiovascular, oncology, molecular biology and biostatistics allows her to understand the needs of innovative medical device manufacturers; and support them in navigating the regulatory waters of certification. By understanding the importance of evidence, not only in written form to peers but also to deliver valuable information to the consumer, BioSciPons is favoured by start-ups in the fields of artificial intelligence, wearables, implants, among other innovative technologies.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
4 April 2025
Live online
08:30-13:30 UK (London) (UTC+01)
09:30-14:30 Paris (UTC+02)
03:30-08:30 New York (UTC-04)
Course code 15550
Until 28 Feb
Not ready to book yet?
for 7 days, no obligation
12 September 2025
Live online
08:30-13:30 UK (London) (UTC+01)
09:30-14:30 Paris (UTC+02)
03:30-08:30 New York (UTC-04)
Course code 15551
Until 08 Aug
Not ready to book yet?
for 7 days, no obligation
5 December 2025
Live online
08:30-13:30 UK (London) (UTC+00)
09:30-14:30 Paris (UTC+01)
03:30-08:30 New York (UTC-05)
Course code 15552
Until 31 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
1 day
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: