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Global Medical Device Regulatory, Reimbursement, and Policy Review

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Regulatory & Reimbursement

Monitoring Notified Bodies: EU Plans Public Dashboard With MDR Metrics

  • 13 days ago
  • David Filmore

The European Commission is expected to release a public dashboard this summer with regularly updated metrics on how notified bodies are performing on MDR and IVDR conformity assessments. Exactly what information will be disclosed remains to be seen; industry representatives hope it will clarify how much time bodies are spending on innovative versus legacy devices, and on SMEs versus large medtechs.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

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Regulatory & Reimbursement

Pathways Document Depot: Cataloging Medtech Policy

  • 3 days ago
  • David Filmore

A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

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Regulatory & Reimbursement

Consultants Corner: Working for Least Burdensome With Tim Marjenin

  • 13 days ago
  • David Filmore

“Least burdensome” has become an indelible, almost foundational element to how medical device firms engage with the FDA regulatory process. But it’s not magic. You have to put in the effort, and show your work, to convince the agency why your data plan is just what’s needed to answer the question at hand, explains MCRA’s Tim Marjenin in this edition of Consultants Corner.

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QSR is Dead, Long Live QMSR? 5 Topics to Watch in FDA’s Proposed Quality Framework

  • February 22, 2022
  • David Filmore
  • Market Pathways

FDA’s plan to revamp the US Quality System Regulation in the image of the global ISO 13485 standard won’t be as significant a reform as it sounds, FDA argues in its long-anticipated proposed rule out this week. But although QSR and 13485 have a lot of similarities, there are important distinctions FDA needs to work out in its newly proposed Quality Management System Regulation. Here are five areas to pay attention to.

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