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

The Conference will focus 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 will give two papers at the conference: Daniela Karrer, VP Operations and Clinical Affairs, will speak on the second morning, on the subject of ‘Post-Market Clinical Follow-Up in Europe: Strategies and Practicalities’, while Matteo Mosso, Director, Clinical Affairs, will speak 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.