Software as a Medical Device (SaMD) EU MDR Compliance
Navigating the realm of Software as a Medical Device (SaMD) within the EU Medical Device Regulation (MDR) can be a…
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New MHRA Outline: Enforcement Activities for UK Compliance
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a new outline containing enforcement activities to ensure compliance with medical…
New IVD Guidelines: Performance Studies
On May 16, 2024, new guidelines for performance studies involving in vitro diagnostic medical devices (IVDs) were announced by the…
Updated IMDRF Terminologies for Adverse Event Reporting
The overview of International Medical Device Regulators Forum (IMDRF) terminologies for categorized Adverse Event Reporting (AER) (i.e., Medical Device Problem)…
MDCG Guidance: Streamlining Notified Body Processes Under EU MDR and IVDR
The Medical Device Coordination Group (MDCG) has issued four new guidance documents to streamline the processes for Notified Bodies under…
European Authorized Representative Under MDR/IVDR: IGJ Inspection
The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards.
Post-Market Surveillance (PMS) and Vigilance: US & EU Guide
According to the EU MDR, post-market surveillance (PMS) is the “proactive,…
Prioritizing Device Regulatory Approval: FDA Approval or CE Mark
With a projected revenue in 2024 of US $182 billion and an estimated annual growth rate of 5.49% (CAGR…
MHRA’s AI Airlock Pilot Project Revolutionizing AI Medical Device Regulation
The MHRA have started a pilot project in response to a white paper published in 2023…
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