The American Conference on Clinical Trials and Regulation of Medical Devices (CTRMD2023) took place in Orlando, Florida, USA, on 20-21 November 2023. The conference was of special interest to regulatory affairs, clinical trials, and quality assurance individuals working in the field of medical devices.

The Conference focused on the following key areas:

• Regulatory Updates and Trends
• Combining Regulatory/Clinical and Reimbursement Strategies
• Challenges in Regulating AI/ML Medical Devices
• Cybersecurity Trends and Updates
• First in Human/Pilot Study – Tips & Tricks
• Clinical Data vs. Real World Evidence
• Quality Management Systems and MDSAP
• Clinical Evaluation Process and Report
• The Role of Risk Management in Pre- and Post-Marketing
• Post-Market Activities – Dos and Don’ts
• Usability/Human Factors Trends and Updates

Donawa Lifescience personnel gave two papers at the conference: Daniela Karrer, VP Operations and Clinical Affairs, spoke on the second morning, on the subject of ‘Post-Market Clinical Follow-Up in Europe: Strategies and Practicalities’, while Matteo Mosso, Director, Clinical Affairs, spoke on the first afternoon, covering the topic of ‘Medical Device Clinical Investigations in Europe in the MDR Era’.

Further information on the conference can be obtained from the CTRMD2023 official website.