One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an ...

Optical micro overmolding combines micro molding with lead-frame or insert processes to achieve precision, clarity, and ...

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing ...

The project will create at least 200 new, full-time jobs over the next three years and retain 1,704 existing full-time positions. The Commonwealth is supporting the project with $1.5 million in state ...

Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.

The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts ...

Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, ...

Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and ...

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced ...

Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider. Audit Trail Compliance And What To Look For In Mitigation ...

Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.