Medical Device Training Software Systems

Medical Device Training Software Systems are Specially Designed to Automate Personnel Training and Competence for the Quality System Regulation QSR and 21 CFR 820 Regulations

MasterControl's medical device training system is an integrated part of the MasterControl quality software suite, automates training management processes in an efficient and cost-effective manner.

Watch Videos View Medical Device 3-Minute Demo (3:00) MasterControl Training Module (2:29) How MasterControl Makes Your Job Easier (3:50)

MasterControl understands that training control is equally important for medical device manufacturers that are ISO-certified that’s why MasterControl introduced medical device training software. ISO 13485 requires that a manufacturer assess the training needs of its employees, ensure that they are adequately trained, and maintain a record of employee competence. ISO 9000 has similar requirements pertaining to personnel training and competency.

How can Medical Device Training Systems Benefit Medical Device Manufacturers?

MasterControl medical device training system is a robust, easy-to-use solution designed to effectively manage the training process and integrate it with other processes critical to FDA regulatory compliance, such as CAPA, change control, audit, and customer complaints.

Here's how MasterControl medical device training software addresses some of the major challenges that medical device manufacturers face in establishing and maintaining an automated training management software system:

QSR / Part 820 Training Management Challenges		MasterControl Training Software Solution
Inefficient Training Management System The more employees a company has, the harder it is to track, follow-up, and verify their training, especially if they're in different locations working different shifts but MasterControl provides the right medical device training system for this problem. A paper-based system is likely to result in voluminous paperwork, delays, or incomplete training tasks.		Efficient Training Management and Tracking Software MasterControl's medical device training software automates the routing and delivery of training tasks and even automatic grading of online exams. Provides a secure, centralized, and Web-based repository for all training-related documents.
Disconnected Training Processes Changes made to SOP and other key documentation almost always requires new training. If the medical device training system is not connected to change control and other quality processes, training tasks are likely to fall through the cracks.		Connected Training Software System MasterControl medical device training software integrates the training process with the rest of the quality system for a holistic approach. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and training of employees on the new SOP.
Poor Communication Tracking calls for two-way communication. The training coordinator needs to inform all trainees about their tasks and trainees need to communicate back upon completion of training. In between, there's a need to remind people or escalate tasks. Paper-based and hybrid systems create unnecessary work with uncoordinated e-mail messages, phone calls, and face-to-face communication that are difficult to track. MasterControl offers medical device training system which provides easy access and smooth communication between departments while training.		Efficient Communication Automates tracking and follow-up. Users are automatically notified about new training tasks. In the medical device training software, upon completion of the task, the verifier is also automatically notified. Trainees have access to their training records with a personalized folder that shows past training, course due dates, and future training.
Lack of Oversight With a paper-based or hybrid system, it's hard to find out who needs what training when, or how many employees passed or failed the training. It's almost impossible to get the status of the training program in a timely manner but with MasterControl's medical device training system, all statuses can be managed from one place.		Increased Oversight MasterControl's medical device training software consists of an advanced analytics and reporting capability which includes customizable reports and online charting. The training coordinator can run a report according to required training by trainee, completed training by job code, or pending training by course, and find out how many people have completed their tasks.

MasterControl's Medical Device Training Systems

ISO standards and GMP regulations specify that medical device developers conduct and document satisfactory employee training courses to make certain that all personnel know how to properly perform tasks according to industry and company guidelines. Inadequate or outdated medical device training systems inevitably lead to substandard products. Thorough and accurate tracking of medical device training can help companies avoid unfavorable regulatory audit findings that could disrupt production. Medical device/equipment companies like Aplicare, Verathon (formerly Diagnostic Ultrasound), and Stryker Medical have successfully implemented MasterControl medical device training software solutions to help them maintain compliant training programs.

The MasterControl medical device training system is completely configurable and capable of meeting the unique standards of any company in a regulatory environment. MasterControl Training automatically assigns and monitors training tasks and grades exams online. Pertinent training courses are seamlessly sequenced to streamline the training programs vital to the long-term success of regulated companies.

Features of Medical Device Training Software

Here's a summary of MasterControl Training's powerful features:

Online Exams - Regulatory bodies are increasingly seeking proof of personnel competency through the use of testing. MasterControl's medical device training software automates the assignment and follow-up of training tasks and even grading of online exams.

Training Curriculum - MasterControl allows development of a progressive medical device training system through sequencing of training courses. As soon as a trainee completes a prerequisite, the next course is automatically launched.

Group Sign Off - For companies with hundreds of employees being trained at once, verifying and signing off for each trainee can be time-consuming. With the group sign-off feature in the medical device training software, the course instructor or verifier can sign off once for large groups of trainees.

Revision Control - With MasterControl's automatic revision control, only one authorized user at a time can revise a particular training material. Trainers and course managers can rest assured that there are not multiple versions of a course being acted upon.

Connected Quality Processes - MasterControl medical device training software connects training with other quality processes, so any course or linked document that has been changed and re-approved will automatically trigger training tasks for all affected trainees.

Advanced Analytics and Reporting - MasterControl medical device training system automatically performs gap analysis for all training tasks - all the time. It tracks and shows any training deficiencies that might jeopardize compliance. Training coordinators can monitor the entire quality management lifecycle, from input to closure. Managers will get the big picture with the help of the following reporting capabilities:

• A medical device training system have an ability to dynamically capture, trend, and link data needed to solve problems, improve processes, and implement preventive measures. A variety of reports come standard, but companies can customize reports based on their needs.
• Data can be grouped together by a date interval and then charted over a date range.