-:This Thanks Giving Plianced brings you Complimentary webinar:-

Medical Device Risk Management: Implementing ISO 14971:2019

Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting harder.
ISO 14971 is being revised. The new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes and moves them to a new document.
And at the same time the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side effects (residual risk) and benefit-risk analysis as a life-cycle requirement.
Are you prepared for these changes? Have you worked on risk analysis and evaluation with your team? Are your risk management files and plans up-to-date?

Attend our complementary webinar and learn

  • Risk management files and plans
  • Acceptable risk definitions and the risk matrix
  • Risk analysis, evaluation and control
  • Residual risk evaluation
  • Risk management review
  • EU-MDR adjustments and expectations
  • ISO 14971:2019 implementation and process standards
  • Annex I risk-specific requirements

Register for FREE

    Target Audience:

    Anyone responsible for completing an OSHA 300 Log, including:

    • Risk Managers
    • Quality Assurance/ Quality Control Personnel
    • Regulatory Compliance Professionals
    • Document Control Personnel
    • Regulatory Affairs Professionals
    • Quality and Manufacturing Engineer
    • Supplier Quality Managers
    • Quality Auditors