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DITTA's Involvement in the 15th IMDRF meeting

19-21 March 2019, Moscow, the Russian Federation

 

DITTA had an important delegation of experts present at 15th IMDRF meeting in Moscow.

 

DITTA/IMDRF joint workshop - Optimizing Standards for Regulatory Use

The IMDRF Standards Working Group and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) held a joint workshop on topics related to the final document: Initiates file downloadOptimizing Standards for Regulatory Use (IMDRF/Standards WG/N51 FINAL:2018).

The Workshop was held on 18 March 2019. Standards help ensure that devices are safe and perform as intended and, as such, can be used for regulatory compliance. Internationally recognized standards facilitate regulatory convergence at the global level.

IMDRF recently adopted the guidance document Optimizing Standards for Regulatory Use. This workshop explored how regulators and standards developers will use the recommendations of the guidance at a practical level. In addition, the next steps for the IMDRF and its activities on standardization are discussed. Information will also be shared on specific standardization activities in IEC and ISO.

Refer to other links hereafter especially pictures taken during the workshop.

Please find all DITTA Workshop presentations Initiates file downloadhere

 

IMDRF-15 Open Stakeholders Forum

The IMDRF-15 Open Stakeholders Forum was held on 19 March 2019.

More than 300 delegates from medical devices manufacturers industry, research institutions, federal executive authorities, federal state budgeted institutions, foreign regulatory authorities and international organizations took part in the Forum.

 

Please find here:

  • The agenda of the IMDRF Stakeholders Forum Opens external link in new windowhere 
  • DITTA presentation at the Open Stakeholders Forum Initiates file downloadhere

Other links: