k.janecek2024-02-29T16:44:37+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: CDRH, Clinical Trial, Compliance, FDA, Medical Devices, MedTech, Regulatory, Regulatory Affairs, USA|
The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]
k.janecek2023-03-29T14:06:17+00:00February 16th, 2022|Categories: Compliance, Europe, Regulatory|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, MDCG, Medical Devices, Regulatory, Regulatory Affairs|
In accordance with the conformity assessment procedures (described in Article 48 of IVDR), in addition to quality management system and technical documentation assessments, notified bodies are required to verify product batches of class D IVDs in line with Annexes [...]
adminMTE_04792023-03-29T15:49:01+00:00December 1st, 2021|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Investigation, Clinical Trial, eumdr, Europe, European Union, MDCG, Medical Devices|
New guideline for Europe on trial changes has been published! MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation. The sponsor of a clinical investigation is required to submit an application to the Member State in [...]
adminMTE_04792023-03-29T15:49:17+00:00November 4th, 2021|Categories: Various|Tags: 510K, BLA, denovo, Device Software, FDA, HDE, IDE, Medical Devices, PMA, SaMD, SiMD|
FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. This document is intended to cover: ▪️ firmware and other means for software-based control of medical [...]
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