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Post-Market Surveillance and Vigilance Requirements for EU IVDs
Post-Market Surveillance and Vigilance Requirements for EU IVDs

Our Price: $395.00

Product Code: WB-7023

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About the Product
Includes 1 hour and 15 minute Windows Media Video File and PowerPoint presentations for immediate download.

Surveillance and vigilance activities are critical for ensuring patient safety, and EU IVD manufacturers will soon be responsible for meeting new post-market requirements outlined in the draft IVD regulation The revision of the IVDD has been an on-going process for some time and many in the industry are looking forward to a new, harmonized set of rules that aim to improve product safety and efficacy through increased post-market surveillance and vigilance reporting requirements. While these requirements are not final or expected to be adopted until 2014, many companies are anxious to implement appropriate policies and procedures and have greater collaboration and knowledge share with other manufacturers and member states.
  • Interpretations of the IVD regulation for successful PMS across the EU
  • Guidance for building successful PMS and vigilance practices
  • Innovative reporting technologies, requirements and strategies for vigilance data
  • Effectively managing risks to avoid recalls

Dr. Maurizio Suppo
Principal Consultant

Target Audience

  • Post-Market Surveillance and Vigilance
  • Post-Market Safety Reporting
  • Regulatory Affairs
  • Compliance
  • Quality Assurance

Target Industry

  • Diagnostic Manufacturers

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