Lianne Coppinger, director of compliance and regulatory, Cogmedix, West Boylston, MA. Medical device manufacturing takes precision and care, so it is important to be prudent when selecting a contract ...

Customer requirements and regulatory classifications are driving increasingly rigorous quality control protocols in medical device thermoforming, with cleanroom manufacturing emerging as the gold ...

Qosina, a global supplier of single-use components for medical device and life science OEMs, has completed construction of a 1,700-square-foot ISO Class 8 cleanroom. The addition to its ...

Cadence Inc. has announced the addition of an ISO Class 8 cleanroom at its Staunton headquarters, which will be used for development and manufacturing of novel medical devices. “We are excited about ...

Understanding the Requirements for Particle Monitoring in Pharmaceutical Cleanrooms begins with a grasp of the current regulations. The current international standards for defining contamination ...