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.
mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations. Read More
OPTIM Associates is a Medical Device consulting company specializing in Quality Systems design, development, execution and remediation for newly developed products as well as existing fielded products. Our specialty runs the entire spectrum from Start-Up QS & 510(k) to QS Remediation assistance... Read More
Customized FDA and IVD compliant software solutions. apartis develops top quality client-specific software. We specialize in offering solutions to the medical and pharmaceutical sectors, focusing on instrument/system control, data mining, data management, quality control, user interfaces,... Read More