• 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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Whitepaper: Clinical evidence under the European Union Medical Device Regulation 
  • 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