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Understanding Electronic Labeling Requirements for EU Medical Devices
Understanding Electronic Labeling Requirements for EU Medical Devices


 
Our Price: $395.00

Product Code: WB-7062
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About the Product
Includes 1 hour and 20 minute Windows Media Video File and PowerPoint presentations for immediate download.


The recently issued EU Commission Regulation 207/2012 on electronic Instructions for Use (IFU) in medical devices, effective March 1, 2013, is applicable to devices covered by the AIMD (90/385/EC) and the MDD (42/93/EC). The regulation is heavily geared towards manufacturers performing and documenting additional risk assessments which take into account the volatility of technology. In today’s stringent regulatory environment where medical device manufacturers are often required to demonstrate traceability throughout the product lifecycle, accurate labeling is critical.
  • Outlining scope of applicable device and accessory types
    • 90/385/EEC (AIMDD), 93/42/EEC (MDD)
  • EIFU regulatory requirements
    • Risk assessments
    • Website requirements
  • EIFUs benefits and challenges for manufacturers and users

Speaker:

Jayanth Katta
Certification Manager & Product Specialist
BSI


Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Labeling Compliance


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