AI/ML-driven medical devices face distinctive challenges in adhering to regulations, ensuring data security, and safeguarding patient well-being. The collaborative effort of the US FDA, Health Canada (HC), and the UK’s MHRA has yielded ten (10) guiding principles for Good Machine Learning Practices (GMLP). Advocating established practices, healthcare tailoring, and innovation, these principles underscore the criticality of diverse expertise, robust software engineering, inclusive patient representation, autonomous data sets, customized design, human-AI synergy, pertinent testing, transparent user information, and ongoing safety vigilance.
Is unwavering commitment to these principles considered imperative for a triumphant market entry amidst dynamic technologies and stringent Regulatory demands? Gain insights with our thought leadership article published by Med Device Online.