Medical Device

Medical electronics, disposables, surgical, and diagnostics are just a few of the areas the medical device industry surrounds. Companies within these markets must not only comply with the strict FDA requirements, but also ISO 13485.

Medical device companies must be able to support the convergence of technology in a variety of markets. For example, diagnostics also have a biotech component. Imaging, which includes X-rays, MRI, and CAT scans, is an industry within an industry.

Maintenance and calibration play a large role in the medical device field. Departments, such as engineering, QC, production and instrumentation, have both a calibration and maintenance component. The diverse nature of the industry requires an asset management software package to be flexible and compliant for the ultimate in productivity.

Blue Mountain Regulatory Asset Manager combines the calibration, maintenance and validation of equipment into one software package. The software’s flexibility makes it easy to incorporate it into virtually any type of medical device facility. Users can customize field and tab labels and use hundreds of user definable fields throughout the application to collect the exact information they need to collect and use the terminology for a specific industry, company or facility. In addition, users can manage all aspects of their equipment, including loops, work orders, measurement data, inventory, and much more. Regulatory Asset Manager’s diverse feature set makes it easy to meet the strict requirements set forth by the FDA, as well as maintain compliance to ISO 13485.

Calibration Manager is the industry standard stand-alone Computerized Calibration Management System (CCMS), for medical device companies for whom a single consolidated system for calibration, maintenance and validation does not make sense. With over 1000 validated implementations, Calibration Manager was designed for calibration professional to meet the strict regulatory requirements in the medical device industry.