• Identify critical risk-based solutions to ensure sufficient clinical evidence in submissions
• See a visual representation of the most common clinical evidence deficiencies in recent MDR submissions
• Understand how clinical evidence can meet higher standards under EU MDR

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• Learn why the traditional equivalence pathway is more difficult to justify
• Compare alternatives to the equivalence pathway across device classes
• Discover key author & reviewer competencies that regulators, notified bodies, and auditors/inspectors look for

• Identify critical risk-based solutions to ensure sufficient clinical evidence in submissions
• See a visual representation of the most common clinical evidence deficiencies in recent MDR submissions
• Understand how clinical evidence can meet higher standards under EU MDR
• Learn why the traditional equivalence pathway is more difficult to justify

• Compare alternatives to the equivalence pathway across device classes
• Discover key author & reviewer competencies that regulators, notified bodies, and auditors/inspectors look for