MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?
Published: July 21, 2022
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Navigating the 510(k) EO Sterility Change Master File Program
Published: June 29, 2022
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MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices
Published: June 23, 2022
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MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews
Published: June 16, 2022
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MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity
Published: June 1, 2022
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Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry
Published: May 16, 2022
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New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR
Published: May 9, 2022
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The Repeal of MCIT: 3 Key Takeaways for Medical Device Manufacturers
Published: May 2, 2022
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FDA Announces Optional Pathway for Clearance of Surgical Sutures
Published: April 13, 2022
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FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”
Published: April 12, 2022
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New MDCG 2022-4 Guidance Released
Published: March 1, 2022
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Industry Update: U.S. FDA Quality Management System Regulation
Published: February 28, 2022
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FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”
Published: January 31, 2022
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FDA Announces Release of “Playbook for Threat Modeling Medical Devices”
Published: December 3, 2021
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FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions
Published: November 3, 2021
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MDCG Publishes New Legacy Device Guidance 2021-25
Published: October 27, 2021
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