FDA Announces Three New Guidances Dedicated to 510(k) Submissions
Published: September 18, 2023
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Medical Device Packaging Validation: 5 Testing Best Practices for 2023
Published: September 14, 2023
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How ISO 10993-17:2023’s Toxicological Screening Limit Can Change the Game for Medical Device Manufacturers
Published: August 18, 2023
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FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices
Published: August 15, 2023
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How the Updated ISO 10993-17:2023 Could Change Toxicological Risk Assessment
Published: June 29, 2023
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EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)
Published: December 6, 2022
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ISO 10993-18 Primer: Medical Device Chemical Characterization
Published: October 31, 2022
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Why Complete Chemical Characterization Matters for Plastics
Published: October 18, 2022
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Understanding the Complex Combination Product Pathway
Published: October 18, 2022
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First Manual on Borderline and Classification under MDR Published by the European Commission
Published: September 13, 2022
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ISO 10993-1 Primer: Medical Device Testing for Risk Management
Published: July 13, 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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FDA Announces Optional Pathway for Clearance of Surgical Sutures
Published: April 13, 2022
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Overcoming Obstacles to Tissue Sterilization Validation: What Manufacturers Need to Know
Published: February 21, 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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Are You Prepared If Your Disinfectant Is Discontinued?
Published: November 8, 2021
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