Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers ...

Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers and document owners are defined appropriately, approval can be streamlined.

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 ...

The medical devices industry, as well as the pharmaceutical industry, is slowly but indisputably accepting the concept of Quality by Design into its design and development product phases, and is ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...

Quality Management Software - CATSWeb is not just a static data repository, it's a collaborative, real-time dynamic workflow tool that assists you in your problem solving efforts. This software will ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Celanese has recently added to its portfolio the new medical compliant injection moldable GUR® high molecular weight polyethylene 1001 with unique properties. Its high molecular weight is responsible ...

Across industries, innovation platforms constantly monitor device usage and anticipate future needs, fueling breakthrough ideas in real time. AI agents are dissolving silos in large organizations, ...

The Visco-Jet® Micro-Mixer is composed of 36 critically controlled spin chambers that subject the incoming liquids to a vigorously repeated mixing process. The mixing energy is drawn from the liquids ...

Risk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. 1 The main purpose of this analysis is to identify all ...