ARTICLES BY MARCELO TREVINO
The FDA & EU IVDR Regulatory Frameworks For IVD SaMD1/4/2023
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.
Does The FDA Or EU IVDR Consider IVD Software An IVD Medical Device?12/16/2022
Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and regulated as Software as a Medical Device (SaMD). In vitro diagnostic devices are known as IVD SaMD. This article summarizes the regulatory requirements in the EU, governed by the In Vitro Diagnostics Regulation (IVDR), and the requirements in the U.S., governed by the FDA.
Implementing EU MDR and IVDR: Lessons Learned, Part 23/31/2021
The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.
Implementing EU MDR and IVDR: Lessons Learned, Part 13/24/2021
The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!
Implications Of COVID-19: EU MDR Implementation Update7/8/2020
Learn how the EU 2020/561 Article 59 update, progress on guidance documents, formation of Expert Panels, and more affect your company.
Analyzing The Changes To Risk Management Standard ISO 14971:201912/11/2019
The third edition of ISO 14971 and its updated companion report are set for release this month. ISO 14971:2019 will provide clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles.
A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 134855/13/2019
The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.
EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes10/22/2018
Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
8 Key Changes To Understand In The New European MDR And IVDR9/16/2018
The new European MDR and IVDR regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans.
A Simplified, Five-Step Approach To Applying FDA’s Human Factors Guidance4/23/2018
FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices.