The MedTech Summit US is dedicated to EU MDR implementation, FDA policy and digital health.
Topics
- Imperatives for clinical and post market surveillance requirements under the EU MDR and achieve compliance
- EU MDR implementation status, the latest requirements and advice for industry
- How global quality requirements are being streamlined as the FDA aligns with ISO 13485
- Industry case studies and detailed discussion on EU MDR challenges and opportunities
- Real-World Evidence to fulfill reimbursement requirements
- What steps you should take to ensure 510K device approval
- Ideas from industry peers on gaining regulatory approval for software
- FDA regulatory initiatives for software, AI and cyber security
- Security, quality and risk best practice
Who should Attend
Attendees with responsibilities in:
- Quality
- Regulatory Affairs
- Clinical
- Software
- Vigilance and Medical Safety
- Post Market Surveillance
- Medical Device
