Medical Device Regulatory & Engineering Blog

Application Lifecycle Management (ALM) is akin to a maestro conducting a grand symphony, where each section of the orchestra represents a phase in the software's ...

Legacy device manufacturers are currently facing a critical juncture as the last call for transition under the Medical Device Regulation (MDR) approaches within the next ...

The classification of medical devices and in vitro diagnostic (IVD) devices is an important regulatory aspect that varies between the United States (US) and the ...

This article is Part 2 of our series about challenges and strategies for manufacturers to master the transition to MDR. The European Union's Medical Device ...

This is the first part of an article series about MDR transition, what it means for manufacturers and how transition can be sussessful. The European ...

Navigating the complex landscape of medical device regulation in the United States can be challenging, especially for engineers and managers unfamiliar with the FDA's requirements. ...

Dive into the AI Act with our comprehensive overview, designed to guide you through the complexities of data governance in the AI era. Understand the ...

Navigating the intricate framework of 21 CFR Part 820, the federal regulation specifically addresses the quality system requirements for the manufacturing, labeling and packaging medical ...

Benefits of an eQMS for a medical device company start at the audit table. Short answer: an electronic quality management system turns the records ISO ...