Global Regulatory Landscapes for In Vitro Diagnostics (IVDs): A high-level view of the IVD regulations in the US, EU, Asia-Pacific, etc.
Impact of the EU's In Vitro Diagnostic Regulation (IVDR): Deeper dive into the European IVDR regulations and specific topic areas related to IVDR
Clinical Evidence and Performance Evaluation for IVDs: Requirements for generating and presenting clinical evidence and performance data in the US and EU