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Compliance, an Ongoing Challenge for Medical Device Manufacturers

September 14 2016 | (1) Comment

istock_000038963684_mediumThe ever changing landscape of regulatory and compliance requirements is a main concern for medical device manufacturers. The evolution of these changes can have a significant impact on the internal processes and profitability for these companies.

Medical device manufacturers continuously strive to launch new products while effectively reducing the costs and risks of compliance. This poses ongoing challenges that require a great deal of strategic planning, flexibility and investment in tools to help alleviate these constant pressures.

Training is an integral part of compliance.  For example, the FDA not only requires that drug and device manufacturers train their employees, but they put the burden on firms to establish comprehensive procedures that specify how employees will be trained and how those training records will be kept.  A comprehensive training program includes performing needs assessments, implementing training programs, evaluating training program effectiveness, and making sure all training records are accurate and up to date.

Managing training compliance can easily become an arduous task unless organizations choose to invest in technology that can automate the process for them. Training software, such as a Learning Management System (LMS) can keep your training initiatives on track and in compliance.   Implementing an LMS offers many benefits, such as real-time visibility into your company’s compliance activities, cost savings and above all – risk mitigation.

The bottom line is that as medical device manufacturing companies address new opportunities to become more competitive and profitable; their ability to integrate technologies to meet regulatory compliance requirements will be a critical factor to their success.

Would you like to learn more about hos an LMS can support your compliance initiatives?   Check out some of our informational whitepapers here:   https://www.epathlearning.com/resources/white-papers/#Pharma/Bio

Susan Distasio | eLearning Industry Crusader | ePath Learning, Inc.

SuzieD-4About the Author:  Susan Distasio is an eLearning Industry Crusader focused on advocating for advancement and change in the eLearning and professional development industry.  An avid seeker of knowledge and continuous improvement, Susan is happy to share her research, observations and thoughts regarding “all things related to learning and development.”  When she’s not out on the learning crusade, Susan can be found with the wind in her hair riding her Harley or simply enjoying life with her husband, Steve, and her Siamese cat, Elvis, and with family and friends.