Medical device manufacturing

In the highly regulated world of industrial manufacturing, compliance with stringent regulatory standards is not just a recommendation – it’s a necessity. One of the most important regulations for companies that maintain records or submit information electronically in the pharmaceutical, medical device, and other regulated industries is FDA’s 21 CFR Part 11.

The Medical Device industry is uniquely complex. It incorporates a wide variety of processes from injection molding to semiconductor deposition and lithography. This diversity creates opportunities but also introduces significant challenges, especially in a highly regulated environment.

Gartner’s strategic technology trends for 2025 showcase the tools shaping the near future, from AI-driven autonomy to sustainable computing paradigms. For manufacturers, these trends represent more than just possibilities—they are an urgent call to action to drive efficiency, resilience, and innovation.

The more comprehensive a manufacturer’s understanding of their entire value chain is, the more effectively they can optimize production, regulatory compliance, and ultimately, profitability.

The manufacturing industry is undergoing a seismic shift driven by digital transformation. No longer a futuristic concept, digital transformation is essential for manufacturers operating in today’s competitive landscape. This article provides an overview of this critical initiative–exploring its focus areas, emerging trends, and potential challenges.

Comprehensive state-of-the-art maintenance management modules provide all the necessary functionalities to create and execute maintenance plans along with all their associated activities. And it does not stop at processing the equipment, it includes maintenance planning for all manufacturing assets such as transport or storage systems.

Various factors, such as heightened pricing pressures, stricter regulations, and operational inefficiencies, have transformed the Medical Devices industry landscape. By digitizing their operations, Medical Devices companies can create the momentum needed to achieve sustainable growth and profitability. Here is what you need to know about how digitization processes work.  

If you work in manufacturing, you’ve probably heard a lot of buzz about the Internet of Things (IoT) lately. And for good reason – IoT has the potential to completely disrupt how products are made.

The implementation of an MES CoE offers a strategic solution, aiming to standardize processes and technologies across these diverse environments while fostering agility and responsiveness to shifting business conditions.