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 on a consistent basis.

Training For Medical Device Manufacturers

The Challenge

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 of such regulatory rules is 21 CFR Part 11 which applies to companies in the life sciences industry including medical device manufacturers, pharmaceuticals, and biotechnology. See how eLeaP solves the 21 CFR Part 11 learning management system conundrum.

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.

Addressing the Challenge

The primary way many medical device manufacturers are meeting this challenge is through the implementation of eLearning.

eLearning In Action

Merit Medical Systems has operated as a leading medical device manufacturing organization since 1987. With more than 1,700 employees worldwide, the manufacturer of cardiology and radiology equipment required a more cost-effective, streamlined, consistent way to educate these employees, located in facilities throughout the U.S. and the world.

Through the implantation of an internally-hosted learning management system (LMS) from eLeaP, Merit has been able to address the following issues:

“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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