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.
CT CoreTechnologie, headquartered in Frankfurt, Germany, with locations in the USA, Japan, India, France, Italy, and Japan. CT is the leading provider of 3D Computer Aided Design (CAD) translation software known as 3D_Evolution® (Conversion, Repair, Simplification, Analysis), 3D_Analyzer (CAD... Read More
At Optimal Device we are engineering consultants focused on design and analysis. We provide, train and use engineering software from Dassault Systèmes (3DS) daily on consulting projects which includes such tools as CATIA for parametric Computer Aided Design (CAD), Abaqus for Finite Element... Read More
Accupoint Software is a global provider of innovative compliance management systems. Our solutions empower companies of all sizes to make optimal decisions that improve profitability and positively impact operations.