Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Heres why this is ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

The Patent Office has extensively and thoughtfully analyzed legal precedents it is required to follow and attempted to harmonize and synopsize those precedents. 3 Its guidance sets forth complicated ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of ...

As we near the end of 2023, elective surgical procedures, one of the many victims of the COVID-19 pandemic, are recovering to near pre-2020 levels. As a result, several of the large cap medtech ...

Part 1 of this series presented factors that medical device developers should consider when executing HFE studies internally, detailing how to overcome obstacles while acknowledging that executing ...

On Dec. 8, 2021, CEN, the European standards body, released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This edition, ...