Compliance, an Ongoing Challenge for Medical Device Manufacturers

The 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.

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