MDCG Releases Guidance on Classification of Medical Devices (MDCG 2021-24
Published: October 11, 2021
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Regulatory Development Indicates Shift Toward In Vitro
Published: July 30, 2021
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FDA Breakthrough Devices and Safer Technologies Programs: Advantages for Patients and Medical Device Manufacturers
Published: June 7, 2021
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What to Ask Before Submitting Your Medical Device for Approval
Published: June 7, 2021
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May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers
Published: May 25, 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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FDA Qualifies New Cybersecurity Medical Device Development Tool
Published: April 28, 2021
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MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR
Published: April 21, 2021
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Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’
Published: February 8, 2021
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U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan
Published: January 18, 2021
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U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices
Published: January 12, 2021
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New Guidance: Classification of IVD under the IVDR
Published: November 24, 2020
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Preparing for a Pre-Submission Meeting En Route to Regulatory Approval
Published: November 3, 2020
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Preparing Biocompatibility Risk Assessments for International Registration
Published: October 26, 2020
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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin
Published: October 19, 2020
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