Regulatory

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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FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions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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MDCG Releases Guidance on Classification of Medical Devices (MDCG 2021-24

Published: October 11, 2021

Lab setup with pipette and COVID-19 test kit, illustrating NAMSA's medical research.

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

A rare disease patient filling out an online survey on a laptop.

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

Scientist in a lab wearing goggles and purple gloves using a pipette representing NAMSA's biological safety consulting service

Packaging Pitfalls Medical Device Manufacturers Cannot Ignore

Published: May 13, 2021

Doctor types on laptop next to a stethoscope on a desk.

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

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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