Medical Device companies manufacturing and marketing their products in the global market must adhere to very strict quality and process controls, and must have systems and controls in place to satisfy global regulatory requirements, standards and directives, including those of the FDA, European agencies, Asia, and ISO, such as ISO 13485, 21 CFR part 820, and 21 CFR part 11.
Due to the nature of their business, the manufacturing of often complex components, dependence on supply chain vendor quality, and the criticality of consistency in quality of their products and function, medical device companies are subject to some unique requirements within the life sciences industry. For example, ISO 13485 specifies requirements for a quality management system for medical device companies such that they must be able to demonstrate their ability to provide medical devices and related services that consistently meet both regulatory and customer requirements.
A proven Quality Management Solution (QMS) is essential, to manage SOPs, Deviations, CAPAs, Audits, Change Controls and Complaints. The QUMAS QMS ensures that quality standards are measured, maintained, analyzed, and trended for further improvement over time. This QMS provides Medical Device companies with the ability to feed information from one process to another, such as from a CAPA to a Change Control, creating an efficient and effective process environment and reducing duplication of effort, thereby reducing risk.
The QUMAS QMS automates record keeping and speeds up the release of drug batches, ensuring batch release is not held up by paperwork processing. Also, by providing high quality batches from a well-managed manufacturing process, the manufacturer can operate with the confidence that there will be less batch wastage and rework leading to higher margins and profitability for the organization. Brand and reputational risk is reduced, while process and quality improvements are significant.