Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations is a conference that provides practical guidance on navigating EU MDR, EU IVDR, and FDA regulations for medical device software, ensuring compliant development and successful market authorisation.

Key Topics

• Regulatory compliance
  • EU MDR and EU IVDR obligations
  • FDA medical device software requirements
  • International regulatory differences
• Software development and management
  • Best practices for regulated software
  • Configurable devices, systems, and accessories
  • Maintaining quality amid staff changes and evolving IT environments
• Clinical validation and evidence
  • Defining sufficient clinical evidence
  • Clinical validation strategies for software
• Technology and product strategy
  • Distinguishing medical vs non-medical software
  • Splitting software into platforms and modules
  • Balancing innovation with regulatory oversight

Who should Attend

• Product managers and business strategists
• Service and sales managers
• Regulatory affairs specialists and managers
• Legal professionals and compliance officers
• Quality assurance engineers
• Software developers and system analysts
• Technical writers and biomedical engineers
• Clinical validation specialists and usability engineers
• Project managers and clinical informatics managers
• Clinical research associates and R&D engineers
• Risk management moderators