Products & Services: MedIntelliBase EU MDD 2010-Compliant LitReviews

Quick, Comprehensive, Custom, Professional Medical Device Directed Literature Reviews

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MedIntelliBase MDD LitReviews are specifically for medical device companies that must comply by March 21, 2010 with the new European Medical Device Directive. The service includes a comprehensive review by an experienced team of regulatory experts.

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Is your medical device company in compliance with this new requirement?

“After 21 March 2010 the European Union Medical Device Directive will include a requirement that evaluation of clinical data must follow a defined and methodologically sound procedure based on (Ref MDD Annex X)

  • Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:
    • there is demonstration of equivalence of the device to the device to which the data relates, and
  • Or a critical evaluation of the results of all clinical investigations made.
  • Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2″

Source: MDEG – 2009–12-01 MSOG Class I Guidance Rev. 1_2009-06 Compliance and Enforcement group

 

 

  • Complies with the European Union’s Medical Device Directive (deadline March 2010!)
  • Comprehensive view of the literature route
  • Verified findings with objective evaluations by medical literature and regulatory experts
  • Fully documented and referenced point-in-time literature review
  • Establish substantial equivalence to predicate devices
  • Fully referenced & qualified analysis
  • Reports emailed to you or online – accessible any place, anywhere you travel
  • Fully supported and secure online
  • Greatest value of any literature research services available today

 

MedIntelliBase®: Intelligence→InsightAdvantage