Medical Device ERP: The Basics

Whether you are a manufacturer of medical devices or are a manufacturer providing parts for medical devices, the industry has a lot of requirements. These requirements are set in place to ensure the consumer is receiving a device that is safe to use, which is understandable, however, manufacturers are expected to meet these demands while reducing costs and lowering prices. Medical device ERP can help with this task, and many others, but how do you know which ERP system is right for your business? We’re going to take a look at the basics of what medical device ERP should do.

  1. Manage Growth
    The medical device manufacturing industry is in an interesting time of rapid growth. With all of the baby boomers reaching older ages, there is an influx of medical devices needed. Managing rapid growth can be difficult if your business system cannot handle and sustain it, which is why medical device ERP is a better option. It is made specifically to handle this type of growth while keeping your business profitable and efficient.
  2. Product Traceability
    In an industry such as medical device manufacturing, lot tracking and visibility is especially important, not just for those in the industry requiring it but for the safety of customers, as well. Medical device ERP allows the products and components to be tracked from the minute they are created until they are put into the consumer’s hand.
  3. Regulatory Compliance
    From FDA 21 CFR Part 11 to ISO 13485 and cGMP 820, there are so many regulations you need to comply with that you could actually lose money just attempting to do it. The one way you can ensure that you’re complying without losing out on time and money is by automating the process with medical device ERP. This eliminates the possibility of error through manually gathering the data and managing recalls.
  4. Customer First
    The range of customers you can have when manufacturing medical devices is vast. It can be a patient that is using a device by doctor’s orders at home, an in-home nurse or health care worker, or a doctor or surgeon. Their knowledge bases on medical devices vary at extremes and all have different demands and requests. Keeping them all happy and managing them all separately can easily be done by using medical device ERP through the embedded CRM.

The challenges in the medical device industry depend on reducing costs, while also trying to meet regulation and customer demands. One clear way to face this challenge head on is by turning to automation of manual tasks. This way, you can be sure that you are meeting regulations and compliance in the most efficient way possible. This is easily done by leveraging and choosing medical device ERP.

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