Medical Device Quality Control Software Solutions

The FDA's Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to maintain a medical device quality assurance system that uses a total quality approach to ensure product safety and effectiveness. The GMP requirements in QSR are harmonized with ISO 9001 and ISO 13485. Many medical device manufacturers voluntarily adhere to those ISO standards because they are recognized worldwide as a stamp of quality.

Today, in FDA and ISO regulated environments medical device companies are working hard to meet government and industry standards. In fact, many medical device companies are working too hard. Medical device quality control systems in regulated environments is essential. However, many medical device companies spend inordinate amounts of time creating documents via disjointed applications, searching for prior versions of a document, manually routing documents, manually approving documents, etc. This ad-hoc, "do-it-when-you-get-to-it" processes require far too many man hours and way too much busy work. They also affect quality processes such as Corrective and Preventative Actions (CAPA), change control, audits, and training. On the other hand, MasterControl, a provider of integrated medical device quality assurance software systems and services, provides the tools it takes to streamline medical device quality assurance and regulatory compliance processes in a centralized online system.

The MasterControl's Medical Device quality control system is an integrated quality management suite is a configurable, off-the-shelf, and easy-to-use software solution that facilitates FDA and ISO compliance. It integrates different medical device quality processes and connects different departments involved in the compliance initiative. Our medical device quality assurance software automates, streamlines, and effectively manages document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a single Web-based platform.

In addition to providing robust software, MasterControl offers cutting-edge validation tools and services that will help ensure FDA compliance. The MasterControl Validation Solution consists of a continuum of products and services that address different levels of validation needs. It gives companies the choice of either automated or manual validation services based on their risk assessments. The medical device quality control solution dramatically cuts the time involved in validating a system, reduces risks of project implementation, and makes it easier to validate software upgrades, all of which help lower validation cost.

In order to provide complete solutions to common concerns about medical device quality assurance, MasterControl also offers implementation, training, technical support, and validation services.

To learn more about sustaining medical device quality assurance, contact a MasterControl representative today.