• Identifying the necessary documentation for medical device certification in the US
  • FDA expectations
  • Best practices for documentation compilation
• Preparing for FDA inspection and consultations
• Post-approval
  • Responsibilities and processes for manufacturers

• Current status of MDR across Europe
  • Implementation status
  • Transition deadlines
  • Current devices certified
• Industry best practices
  • Working with all stakeholders
  • Utilizing guidance
  • Pathway to approval

Join us for an illuminating 'Ask the Expert' session featuring Dr. Jaishankar Kutty, a guiding light in medical device development, regulatory compliance, and clinical strategy. Currently, as the Vice President of Intelligence and Innovation at RQM+, Dr. Kutty is at the forefront of crafting pathways for innovative healthcare solutions.

In this session, participants will have the unique opportunity to engage with Dr. Kutty, whose deep-rooted experience as a former Technical Team Manager and Clinical Team Leader at BSI has made him a sought-after authority in the industry. Dr. Kutty's specialization in cardiovascular products and his instrumental role in the CE marking process will serve as a guiding light for those interested in understanding the intricacies of medical device commercialization and the criticality of regulatory approvals.

• Understanding the global medical device landscape
  • Streamlining regulations and expectations globally
• Harmonization initiativeso IMDRF
  • GHWP
  • MDSAP
• Pre-market and post-market priorities

• Outlining the differences
  • Stakeholders involved in the US and European regions
  • Differences in regulatory frameworks
    • UK and Swiss markets
• Experiences of submitting in both regions
  • Is it possible to streamline 1 submission for both regions?
  • Common misconceptions for submitting in EU from US manufacturers
• Harmonization initiatives
  • MDSAP
  • IMDRF
  • Future collaboration and impact on industry

• Choosing the PRRC
  • Which team should they sit in?
  • Perceived workload of role
• Relationship with regulators
  • Utilizing point of contact effectively
  • Importance of PRRC in international markets

• Technical documentation in the EU and US
  • Similarities and differences in requirements
  • Streamlining documentation to be relevant for both
• Structure of technical documentation
  • Ordering documentation for clarity
  • Linking documentation to Quality Management Systems

• Breaking down laws – which applies to Software as a Medical Device (SaMDs), Artificial Intelligence and Machine Learning?
  • MDR
  • FDA
  • AI Act
• Competent Authority perspective
  • Expectations
  • Utilizing your competent authority in SaMD and AI/ML development and certification

• Overview of current DDCP regulations
• 2 years post-Article 117
  • How have all stakeholders adjusted?
  • How does Article 117 under MDR differ from FDA regulations?
• Navigating the ongoing 4-year grace period
• Forecasting future regulatory plans for combination products globally

• What are the most common regulatory submission preparation pathways?
• What are the concerns regarding the current method?
• Where do regulatory submission and AI interlink?
  • Regulations and standards to be aware of
  • Using AI to meet global submission requirements
• Which parts of the regulatory submissions process can utilize AI?
  • How can it help streamline global submissions
• Practical tips for implementation
  • Resources and help available to the industry

• Current global UDI implementation status
  • GUDUDI
  • EUDAMED
• Key challenges with implementation
  • Data handling
• Future of requirements – a streamlined approach?

• With MDR having been extended, what impact is there on all stakeholders
  • Competent authority and notified body capacity
• Do all devices qualify for the extension?
  • Terms and conditions of extensions
  • Impact for newcomers and on innovation
• The next few years in light of new extensions
  • Knock on effect for wider global markets