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Machine Device Regulatory Compliance

In today's marketplace, there's more to developing a successful production line than procuring manufacturing equipment. Will the line track product data throughout the system? Are the materials certified? Is the documentation complete? Are the controls secure?

Compliance from Concept to Roll-Out

At Machine Device Corporation we understand that building a machine is only part of your task. We've developed the processes, guidelines, and tools to support you through all phases of the regulatory compliance process. We continually monitor compliance guidelines to make certain all of our employees are trained to deal with the latest changes, and to guarantee that your system complies with all regulations right from the start.

An Integrated Process

It's one thing to design and build a robust manufacturing system. It's another thing to validate it. We understand that the time it takes to build your system is only one part of the schedule. We've developed our ISO procedures to follow those required by GMP and GAMP 4. By designing these requirements into our processes, Machine Device can efficiently support all phases of your validation efforts.

The Right Tools for the Job

At Machine Device we've utilized our broad range of experience to develop the tools and processes to support your regulatory efforts. Our documentation templates provide a concise and consistent foundation to support all your regulatory needs. From Functional Specifications and a Traceability Matrix to Engineering Acknowledgements and Project Change Notifications, you can be sure that each step of your project is thoroughly documented. We've developed tools to allow us to communicate with you quickly and efficiently anywhere in the world.

Regulatory Experience

Machine Device’s history of supporting clients in their validation and regulatory efforts is second to none. Whether you're starting development of a new product pilot line or ramping up to commercial manufacturing, Machine Device has the expertise to assure that your system is validated expertly and efficiently. From training and preventative maintenance to life cycle directories and test plan development, we're there every step of the way. Our regulatory experience includes GMP, GAMP 4, CE, UL, and ISO.

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