Tag: Medical Device regulatory

How Post-Market Surveillance Enhances Medical Device Safety

Medical Devices March 15, 2024

Understanding Post-Market Surveillance:In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the...

MDCG Guidance on Clinical Investigation: Timelines | MDCG

Medical Devices January 18, 2024

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Introduction | RegDesk

Medical Devices December 20, 2023

FDA eSTAR Submission Template: A Guide to Navigating the Process | Operon Strategist

Medical Devices December 14, 2023

Navigating the Future: Insights from the 13th China International Medical Device Regulatory Forum (CIMDR) and Anticipating the 14th CIMDR in 2024

Medical DevicesDecember 13, 2023

As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...

Our Top 10 Medical Device Videos of 2023

Medical DevicesDecember 1, 2023

The number of StarFish Medical YouTube subscribers grew by 32% in 2023 and social media views increased an amazing 100%. This round-up features the...

RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva® Allograft Dermis in Breast Reconstruction | BioSpace

Medical DevicesNovember 26, 2023

ALACHUA, Fla., Nov. 27, 2023 /PRNewswire/ -- RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA)...

A Quick Guide to the Medical Device Regulatory Requirements in Lebanon (Compliance and Success) | Operon Strategist

Medical DevicesOctober 9, 2023

SEO Powered Content & PR...

MDR Extension Timeline for Implementation

Medical DevicesSeptember 9, 2023

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

MDR Extension According to Regulation 2023/607

Medical DevicesSeptember 9, 2023

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

Four Foreign Manufacturers Registered Raw Materials in Master File in August

Medical DevicesAugust 20, 2023

NMPA renewed the list of raw material master files on August 14, 2023. Four foreign manufacturers became master file owners for their raw materials...

RegDesk’s AI is Revolutionizing Regulatory Compliance for MedTech Industry | RegDesk

Medical DevicesJune 15, 2023

Technology has the power to streamline redundant processes. Then, why does regulatory compliance for medical technology and devices...

MHRA Roadmap on Software/AI Framework Improvement: Cybersecurity

Medical DevicesMay 1, 2023

The new article highlights the aspects related to cybersecurity for software-based medical devices intended to be marketed and used in the UK. Table of...

MHRA Roadmap on Software/AI Framework Improvement: Cybersecurity | RegDesk

Medical DevicesMay 1, 2023

The new article highlights the aspects related to cybersecurity for software-based medical devices intended to be marketed and used in the UK. Table of...