Medical Device Manufacturing: Addressing Challenges in a Highly Regulated Industry

The medical device manufacturing industry is unique, in large part due to the specific standards and regulatory requirements that must be met consistently. The medical device manufacturing industry is also one dictated by extensive regulations, which means effective compliance training is necessary. Medical device training programs help organizations in this space stay in compliance with federal and state organization in this space stay in compliance with federal and state compliance regulations.

Training For Medical Device Manufacturers

The Challenges of Training Medical Device Manufacturers

For many medical device manufacturers, the primary challenge in this industry exists in properly and continuously training employees to maintain compliance and meet all regulatory guidelines. One such regulatory rule is 21 CFR Part 11 which applies to companies in the life sciences industry, including medical device manufacturers, pharmaceuticals, and biotechnology.

Using the eLeaP learning management system (LMS), those in the medical industry have been able to assuage the challenges set by 21 CFR Part 11, particularly involving the protection of user data. eLeaP ensures safety by requiring all users to provide their distinct User ID and password. If a user seems suspicious, administrators can regulate what information available to them or outright block the user.

Furthermore, eLeaP fulfills the requirements of regulation 21 CFR Part 11 by providing real-time progress reports that employees confirm with an electronic signature. This way, whenever an administrator needs to, they can access learners’ progress via a date-stamped and easy-to-read report.

However, one of the primary regulatory requirements is the International Organization for Standardization (ISO) Specification 13485.

ISO 13485 requires medical device manufacturers to do the following:

Essentially, this high level of quality management requires well-trained employees, with a variety of learning opportunities at their disposal. eLeaP LMS is prepared to help address this regulatory requirement and keep your medical device manufacturers in compliance.

Addressing the Challenges of Training Medical Device Manufacturers

The primary way that many medical device manufacturers are meeting this challenge is through the implementation of eLearning. eLearning offers medical device manufacturers an opportunity to not only provide constant education at a reasonable cost but also to save other resources, maintain productivity, and increase efficiency. An LMS makes these changes achievable by presenting information in a straightforward, streamlined, and engaging format.

Whereas in previous times, employee training consisted of conferences and seminars, eLearning puts education directly into the hands of the worker. They can access their training while mobile as long as they have an Internet-capable device. Employees will no longer be required to sacrifice billable hours just to maintain their compliance. Instead, they can complete courses from wherever they see fit and at a time that suits their schedules.

As well, presenting course material online presents the opportunity to make it as engaging as possible. A digital platform allows for a host of multimedia effects that are simply not feasible in a brick-and-mortar classroom. They could run the gamut from videos and audio to full-on games and activities. At the end of the day, for employees to retain information, they should first engage with it. Once they’re interested in the course, they’ll be more likely to actualize their training.

Keeping Training Records for Medical Device Manufacturers

When dealing with strict regulations and potential audits, medical device manufacturers are required to keep detailed records of everything from course attendance to certification. The introduction of eLearning automatically meets all of these challenges.

eLeaP keeps detailed progress reports of every time an employee logs into the LMS. Reports are time-stamped to keep evidence of when they complete assignments, allowing administrators to follow when the staff has finished modules and met their certifications. Administration can even require that employees electronically sign their reports to guarantee security.

Using eLearning, it’s much simpler to identify potential weaknesses in the quality control process, and then address these weaknesses quickly and effectively. eLeaP allows for bidirectional feedback so that employers can identify where their workers need further training and employees can note where they feel their education needs more development.

Staying Current In These Times

With the current state of the world, the manufacturing of medical devices in such high demand. As a member of that industry, the last thing that you should be worrying about is whether or not your compliance software is out of date. Fortunately, with eLeaP’s open-source, cloud-based LMS, your worries are completely put at ease. Rather than having to maintain an IT team to service the system, eLeaP regularly updates our product through the web. As long as your LMS is connected to the Internet, you can be sure that you are working with the most recent patch.

You will be able to continue addressing the needs of your employees, no matter the situation, by rapidly and remotely adopting new training plans to fulfill regulations. As things continue to change every day, it is vital that your workers stay up to date not just to meet compliance but also to make the most of their training.


Considering the number of regulatory requirements and highly specific standards placed on the medical device manufacturing community, meeting federal and state compliances is an absolute must to remain a viable option in the industry. This is particularly true regarding regulation 21 CFR Part 11. To meet this standard, manufacturers must maintain a staff of high-trained employees with continuing educational opportunities at hand. As the industry continues to develop and change, employees must stay up to date.

Implementing an eLearning option can quickly and easily resolve the challenges presented by this regulation. eLeaP is here and ready to help you meet compliance. You can contact us at 1-877-624-7226 or email for more information about pricing or services.

“eLeaP has permitted our small technical staff to focus on other projects that are more unique and critical to our line of business, while knowing that the learning management system is fully functional and meeting our internal customer needs.”—Lincoln Cannon, Director of Web Systems at Merit Medical

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