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EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

Posted 2 years ago

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Auditing a QMS According to ISO 13485

Posted 2 years ago

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FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software

Posted 2 years and 2 months ago

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Digital Health Software Pre-Certification Update: Final FDA Report Revealed

Posted 2 years and 2 months ago

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First Manual on Borderline and Classification under MDR Published by the European Commission

Posted 2 years and 3 months ago

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MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs

Posted 2 years and 3 months ago

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MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR

Posted 2 years and 4 months ago

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MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?

Posted 2 years and 5 months ago

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Navigating the 510(k) EO Sterility Change Master File Program

Posted 2 years and 5 months ago

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MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices

Posted 2 years and 6 months ago

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MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews

Posted 2 years and 6 months ago

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MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity

Posted 2 years and 6 months ago

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Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry

Posted 2 years and 7 months ago

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New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR

Posted 2 years and 7 months ago

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The Repeal of MCIT: 3 Key Takeaways for Medical Device Manufacturers

Posted 2 years and 7 months ago

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FDA Announces Optional Pathway for Clearance of Surgical Sutures

Posted 2 years and 8 months ago

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