Speaker Profile
RACHELLE D'SOUZA
Rachelle D’Souza began her career in regulatory compliance in 2007. She has provided Regulatory Affairs, Quality Assurance, Clinical, Pharmacovigilance and Medical Information support to the Pharmaceutical, Biologic, Generic, Natural Health Product, Dietary Supplement, Medical Device, Cosmetic, Pesticide and Food industries. Rachelle has developed regulatory strategies, independently prepared regulatory submissions and secured product and site approvals from global regulatory agencies. She has also designed, implemented, and maintained global quality, pharmacovigilance and medical information systems. Rachelle’s regulatory articles and webinars on the latest global regulatory developments have been published in print and online by regulatory professional associations, webinar hosting platforms and industry magazines. Email: rachelle@regulatoryheights.com URL: https://regulatoryheights.com
Rachelle D'souza
February 26 2025
01 : 00 PM EST
90 Minutes
Principles and Practices for the Cybersecurity of Legacy Medical Devices by the International Medical Device Regulators Forum
The International Medical Device Regulators Forum (IMDRF) that comprises of global regulatory authorities as stakeholders, including those in North America, EU, Asia, Australia and more, has recommended various principles and best practices including responsibilities for the medical device manufacturer and the healthcare professional for the management of legacy medical devices throughout the device life cy..
Rachelle D'souza
March 25 2025
01 : 00 PM EST
75 Miuntes
FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
The US FDA has determined that a predetermined change control plan or PCCP be included in the marketing submission for a medical device software that incorporates AI or machine learning models and algorithms. Manufacturers of AI or machine learning software devices are to anticipate or foresee potential modifications post FDA approval and these could be based on perceived risks foreseen or effectiveness imp..