What Is Device Compliance and How Do You Document It?

Devices in various industries must follow device compliance policies, and manufacturers must provide documentation to prove their adherence to these regulations. Understanding what device compliance is and how to record it helps companies improve their products’ quality and safety.

What Is Device Compliance?

Device compliance refers to the state of devices meeting the standards and regulations for the industry. Achieving device compliance is beneficial for:

  • Manufacturers: Manufacturers can promote the development and production of quality devices while reducing costs and increasing profits.
  • Customers: Customers will be satisfied with the integrity of the product and the competitiveness in the market.
  • Organizations: Organizations that use these products — such as a drug manufacturer or hospital — can be confident they will perform as intended.

Different policies exist across industries for device compliance with the American Society for Testing and Materials (ASTM) and the Food and Drug Administration (FDA). Companies must adopt these standards for safety and efficacy.

FDA Device Compliance

The Food and Drug Administration (FDA) protects public health by regulating device compliance and conducting other tasks. This entity has many standards and regulations for various industries. For example, it regulates many medical devices such as pacemakers, prosthetics and surgical implants. The FDA also has standards for the equipment in food and dietary supplement processing. Failure to adhere to FDA standards may result in an inspection citation and actions from the FDA to enforce these laws.

Device Compliance Standards for ASTM

The American Society for Testing and Materials (ASTM) is an organization that develops and publishes technical standards to make procedures safer for various industries. ASTM standards are in place for many systems, products, services and materials. ASTM does not enforce its standards. Companies can adopt the standards that apply to their industry, require ASTM compliance for particular contracts or generate material data sheets that outline ASTM requirements.

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How to Document Device Compliance

Documentation is essential for meeting device compliance policies for the FDA and ASTM. Documentation is required because:

  • It demonstrates your compliance.
  • It supports the safety and effectiveness of your products.
  • It proves your processes are repeatable, consistent and reproducible.

Document control encompasses the policies and procedures your company can use to manage your documents as different departments use them. With a standardized process for managing these documents, you’ll benefit from:

  • An easier way to sort your records and their history.
  • Better document security.
  • Quicker access to your documents and their versions.
  • Accountability for all your practices and procedures.

One of the easiest methods for documenting device compliance is the Digital Qualification Notebook (DQNB) software from HunterLab. This solution helps users create a comprehensive qualification notebook for the compliance and validation of HunterLab instruments. The program walks users through step-by-step instructions for documenting their instruments and protocols. These inputs are gathered into a printable notebook.

Meet FDA Device Compliance With HunterLab

HunterLab has the validation and compliance software you need to prove your adherence to FDA and ASTM regulations. We offer on-site installation and training to help your team get the total value from this product.

Implement a device compliance documentation system with HunterLab’s software solutions. Contact us online to request more information.

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