ETFOptimize | High-performance ETF-based Investment Strategies

Quantitative strategies, Wall Street-caliber research, and insightful market analysis since 1998.


ETFOptimize | HOME
Close Window

Medical Device Software Global Market Access Training Course | Explore Regulatory Pathways and Reimbursement Strategies Across Jurisdictions (ONLINE EVENT: September 8-9, 2025) - ResearchAndMarkets.com

The "Global Market Access for Medical Device Software Training Course" training has been added to ResearchAndMarkets.com's offering.

This course will provide a clear understanding of different market access requirements for medical device software.

As demand surges for Digital Health (DH) solutions worldwide, understanding and navigating international regulations is paramount for market access success. This course will equip professionals with the knowledge to successfully enter into different international markets, improving the chances of commercial success by understanding country-specific requirements.

With an increased impact on clinical management, a higher bar for evidence is required for regulatory approval and adoption, but also an increased stakeholder willingness to pay for the service provided. Although at the moment, there's no one-size-fits all approach, there is a global trend to increase DHT adoption through value-based pricing and reimbursement mechanisms.

This growing trend has prompted countries, both within and outside the European Union (EU), to pilot various market authorization and access schemes, providing guidelines for coverage, and/or clear pathways for reimbursement of DHTs. This intensive course provides a comprehensive overview of the different national DHT market access and reimbursement strategies, presenting an overview of the current state of affairs.

The program will be highly interactive, using real-life examples and state-of-the-art practices across different global jurisdictions. Practical insights will be provide, hands-on exercises, and case studies to guide you through the intricate decisions needed that affect your market access processes.

The course will cover:

  • Impact categories of digital health technologies (DHTs)
  • Market Authorization vs. Market Access
  • Coverage and Health Technology Assessment (HTA)
  • Specifics of reimbursement pathways for DHTs across EU Member States
  • The new Health Technology Assessment (HTA) Regulation, EDiHTA, and ASSESS-DHT
  • Outside of the EU Member States: global reimbursement landscape (e.g., USA, UK, South Korea, Japan, among others)

Benefits of attending

  • Gain an in-depth knowledge to navigate complex market access environments
  • Ensure successful entry into international markets
  • Streamline product development to entry different markets
  • Improve the chances of commercial success by understanding country-specific requirements and approval processes.

Certifications:

  • CPD: 6 hours for your records
  • Certificate of completion

Who Should Attend:

  • Regulatory Affairs Managers
  • Business Strategists
  • Product and Service Managers
  • Sales and Marketing Managers
  • Legal Professionals
  • Compliance Officers
  • Research and Development Engineers
  • Clinical Research Associates
  • Project Managers

Key Topics Covered:

Day 1

  • Impact categories of digital health technologies (DHTs)
  • Market Authorization vs. Market Access
  • Coverage and Health Technology Assessment (HTA)

Day 2

  • Specifics of reimbursement pathways for DHTs across EU Member States
  • The new Health Technology Assessment (HTA) regulation, EDiHTA, and ASSESS-DHT
  • Outside of the EU Member States: Global reimbursement landscape (e.g., USA, UK, South Korea, Japan, among others)

Speakers:

Catarina Carrao

BioSciPons

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.

For more information about this training visit https://www.researchandmarkets.com/r/a30w6y

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com



For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Stock Quote API & Stock News API supplied by www.cloudquote.io
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms Of Service.


 

IntelligentValue Home
Close Window

DISCLAIMER

All content herein is issued solely for informational purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy, nor should it be interpreted as a recommendation to buy, hold or sell (short or otherwise) any security.  All opinions, analyses, and information included herein are based on sources believed to be reliable, but no representation or warranty of any kind, expressed or implied, is made including but not limited to any representation or warranty concerning accuracy, completeness, correctness, timeliness or appropriateness. We undertake no obligation to update such opinions, analysis or information. You should independently verify all information contained on this website. Some information is based on analysis of past performance or hypothetical performance results, which have inherent limitations. We make no representation that any particular equity or strategy will or is likely to achieve profits or losses similar to those shown. Shareholders, employees, writers, contractors, and affiliates associated with ETFOptimize.com may have ownership positions in the securities that are mentioned. If you are not sure if ETFs, algorithmic investing, or a particular investment is right for you, you are urged to consult with a Registered Investment Advisor (RIA). Neither this website nor anyone associated with producing its content are Registered Investment Advisors, and no attempt is made herein to substitute for personalized, professional investment advice. Neither ETFOptimize.com, Global Alpha Investments, Inc., nor its employees, service providers, associates, or affiliates are responsible for any investment losses you may incur as a result of using the information provided herein. Remember that past investment returns may not be indicative of future returns.

Copyright © 1998-2017 ETFOptimize.com, a publication of Optimized Investments, Inc. All rights reserved.