Quality Management + Compliance for Medical Device Manufacturing
Maintaining the highest quality levels, and a strict state of control and regulatory compliance not only affects the bottom line, it can literally be matters of life and death for medical device manufacturers. To protect medical device manufacturing companies, users and meet tough FDA and other regulatory body demands, it is critically important to understand and meet the challenges of integrated, global corrective and preventive action (CAPA); complaints management; audits; supplier quality and overall product quality management; electronic medical device reporting (eMDR); and more. In addition to the FDA’s stringent 21 CFR Part 11 and 21 CFR 820 requirements, medical device companies also face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon medical device manufacturers to use software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it.
AssurX software is designed with global quality management and medical device regulatory requirements in mind. Successful companies use AssurX’s, seamlessly integrated software to centrally monitor, manage and improve their quality and regulatory compliance related processes—and the bottom line—across all operations.
The Tensor monitor was created to help keep your controlled environments in compliance. Track temperature, humidity, barometric pressure, and electrically power quality to ensure your pharmaceuticals are conditioned properly. Included is WiFi or LTE connectivity for instant email/text... Read More
Founded in 1996, PSC Biotech™ has spent more than two decades providing life sciences with essential services and software to ensure that healthcare products are developed, manufactured and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Power Monitors, Inc. is an industry-leading product design and manufacturing firm based in Mt. Crawford, Virginia.
We specialize in applying advanced technologies to develop state-of-the-art power quality recording solutions for residential, commercial, retail, institutional, industrial, and...