A bill of materials is a comprehensive account of everything needed to manufacture a medical device. It includes the raw materials, assemblies, subassemblies, and the quantities of each required for the production of a device.

A bill of materials, or BOM, can be considered the shopping list for manufacturing a particular medical device. With a bill of materials in hand, it is clear what is needed, how it should be acquired, and where it should come from. It will also explain how to assemble the product from the gathered materials.

A well-executed bill of materials helps organize the purchase of materials. It is also used to estimate costs, monitor inventory, maintain records, and reduce waste.

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What is the Purpose of a Bill of Materials?

The bill of materials acts as the basis for production planning. From this foundation, various processes, such as resource planning, cost planning, inventory control, and facility maintenance can pull necessary information.

For a medical device company, a well-managed bill of materials can save revenue spend and prevent investigations, purchasing issues, and other breakdowns in the manufacturing process. Beyond manufacturing, a wide variety of departments rely on the bill of materials, including design, sales, engineering, and inventory management. 

A bill of materials can be tailored to the specific needs of individual departments within a company:

  • Manufacturing bill of materials: includes a list of all items required for the production of the final product. It is structured to provide information about processing of subassemblies as well as the final product.
  • Engineering bill of materials: elucidates the product’s parts and assemblies from a functional perspective, and may include technical drawings. This may be revised multiple times as the product design is refined.
  • Sales bill of materials: lists the finished product and its components. 
  • Cybersecurity bill of materials: lists hardware and software components used in devices. It is used to develop processes that keep devices functioning in the face of vulnerabilities that result from internet connections.

Why is a Detailed Bill of Materials Important for Medical Device Manufacturing?

In medical device manufacturing, a well-constructed bill of materials can reduce revenue loss and delays from conception to marketing of the device. 

The detailed bill of materials allows suppliers and contract manufacturing organizations to provide accurate pricing quotes. It ensures that inventory is properly managed and available as needed during manufacturing.

It provides a roadmap for product assembly so that production is free of deviations that can result in corrective and preventive actions (CAPAs) and even recalls. This means every department involved in development, manufacturing, or sales must pay attention to the bill of materials.

Greenlight Guru Helps to Ensure a Complete and Accurate Bill of Materials

Because the bill of materials is the roadmap that each department must refer to during the manufacture of a medical device, the bill of materials must be kept current and available to all key team members. A single source for the most up-to-date documentation is critical for preventing problems that can occur during the process.

Greenlight Guru’s medical device QMS software is an all-in-one solution that provides a single source of truth through its advanced documentation workflows. Teams across multiple functions and locations can access the most up to date version of their bill of materials at any time to streamline overall work efficiency.


Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →

 

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