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Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

FDA Office of Regulatory Affairs’ Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2 – Central Briefs Medical Alley on Organizational Realignment

Thursday, July 27, 2017

The FDA ORA’s Office of Medical Device and Radiological Health Operations (OMDRHO) briefed Medical Alley Association staff on recently implemented changes to the group’s organizational structure into three major divisions. This realignment will increase efficiency of the office and create new opportunities for cross-training of staff.

Jan Welch, Program Director; Blake Bevill, Acting Division Director; Melissa Michurski, Compliance Officer; and Rhonda Mecl, Supervisory Investigator, briefed Medical Alley Association staff on the changes following a day of meetings with local industry representatives.

Key takeaways from the briefings include:

  1. The realignment will allow for better distribution of staff resources to address needs across the division and program.
  2. Since much of the district office communication is done by phone or email, the location change should have minimal impact on industry/agency interaction.
  3. Greater cross-training opportunities will exist as staff can move across the division and program.
  4. OMDRHO intends to continue its transparency and engagement efforts in this new structure.

The Medical Alley Association will continue to support FDA’s efforts to improve efficiency and quality in both pre- and post-market activities. Thanks to Jan, Blake, Melissa, and Rhonda for sharing their time and knowledge, and to so many members assisting us in the discussion.

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