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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Regulatory Development Indicates Shift Toward In Vitro
Published: July 30, 2021
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What to Ask Before Submitting Your Medical Device for Approval
Published: June 7, 2021
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Packaging Pitfalls Medical Device Manufacturers Cannot Ignore
Published: May 13, 2021
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Safe & Compliant: Mitigating Risks After Device Modifications
Published: May 4, 2021
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3 Regulatory Red Flags with Medical Device Changes
Published: January 28, 2021
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Preparing for a Pre-Submission Meeting En Route to Regulatory Approval
Published: November 3, 2020
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Behind the Curtain: How ISO 10993 Impacts Testing Labs
Published: November 2, 2020
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