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New Contractual Arrangements with Notified Bodies and Suppliers
New Contractual Arrangements with Notified Bodies and Suppliers

Our Price: $395.00

Product Code: WB-7095

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

The September 2013 recommendations require contractual authorization for notified bodies to make unannounced audits, and to perform product sampling and testing at manufacturing and supplier facilities. This simple requirement can have complex practical ramifications, and these new program areas may pose sensitive areas of negotiations for both manufacturers and notified bodies.
  • Many existing contracts did not anticipate the new requirements. What steps can help minimize the impact on manufacturers and their suppliers while fulfilling the Commission’s requirements?
  • Contractual agreement concerning payment for unannounced audits
  • Duty to inform notified bodies of planned shutdowns in order to assist in planning unannounced audits. To what extent must the contract define shutdowns by product line and facility?
  • Agreements to pay for samples and testing if done at a site other than the manufacturer


Elisabethann Wright
Hogan Lovells

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
  • Regulatory Affairs
  • Quality Assurance
  • Legal Counsel
  • Audits

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