White Paper

The Ultimate Guide to Quality Assurance and Regulatory Affairs in Medical 3D Printing

This document aims to guide users in the medical device industry through every stage of the product development process.

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  1. Consider Your Product Requirements
  2. Evaluate All Manufacturing Methods
  3. Compare Additive Manufacturing Methods And Materials
  4. Evaluate 3D Printer And Material Manufacturers
  5. Consider QA/RA Requirements And Constraints
  6. Establish A QMS
  7. Prepare For Process Validation
  8. Commercialization Considerations

1. Consider Your Product Requirements


Products can naturally be produced for various applications and intended uses, including prototyping, hybrid manufacturing, tooling and manufacturing aid, and end-use (or finaluse) devices. The type and purpose of the product can affect materials used, the volume of production, machining technique, lead time, cost, design flexibility, quality flexibility, etc. Various manufacturing methods are available to cover a wide range of applications, geometries, materials, and specifications. When choosing a method, all of the factors listed above must be considered to optimize production.


Once the purpose of your product is defined, you’ll need to consider the material properties required to fulfill the specified purpose. Mechanical and physical properties can affect the materials capable of producing your manufactured part. Examples of material properties include conductivity, density, ductility, hardness, toughness, tensile strength, fatigue strength, and color. Please visit the Formlabs website for a complete list of the most common mechanical and thermal material properties, along with their definitions and functional values. Further, certain materials are compatible with specific manufacturing methods, requiring a holistic approach at the onset of the development process. For more information on material compatibility with specific manufacturing methods, please read the “Manufacturing Methods” section in chapter 2. For more information on additive manufacturing material properties, please refer to chapter 3.


As briefly mentioned above, your part may have particular volume and throughput requirements depending on the product type and purpose. Different manufacturing methods are optimized for varying volume and throughput requirements, impacting each technique’s cost, quality, and manufacturability of specific devices. For more information on each manufacturing method and their optimal use cases, including volume and throughput considerations, please refer to the “Manufacturing Methods” section in chapter 2.

2. Evaluate All Manufacturing Methods

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