Simplifying FDA Compliance for Medical Device Manufacturers


There’s a level of safety and assurance patients hope to feel when going to hospitals and doctor’s offices. While it’s easy to say a patient’s trust might stem from blind faith, Uson does its job in providing more: measured reliability and simplifying FDA compliance for medical device manufacturers.

In order to maintain trust and credibility within the health sphere, codes, and regulations set by the FDA must be met. It’s Title 21 CFR Part 11 that proves most significant to Uson’s latest medical device tester, the Sprint mD. Part 11 defines the criteria under which electronic records and electronic signatures are considered equivalent to paper records.

Meeting FDA Compliance Objectives Through Automation

Today, the medical device industry benefits from increased automation and digitization to achieve their compliance objectives. Plus, electronic records are more cost-effective and ensure data integrity. With faster, more productive access to documentation, medical devices can be created, tested, and released to the public much more effectively.

Measured Reliability with Sprint mD Leak Tester

In order to keep up with the growing demand for innovative medical technology, Uson created Sprint mD. It’s the most effective medical device tester in regard to high-volume production of small parts and devices.

Title 21 CFR Part 11 requires electronic records containing the printed name of the signer, the date and time when the signature was executed, and the intent, such as review, approval, responsibility, or authorship, associated with the signature. Unlike other medical device testers, the Sprint mD supports all three of these requirements, optimizing the testing process so the devices can more quickly enter the medical industry.

In order to meet industry requirements, a few tech advancements needed to be included in the Sprint mD testing device. In order to maintain compliance, the following settings are available:  

  • Sprint mD software requires a username and password combination to edit programs, settings, and other controlled pages in the software. This technology identifies authorized individuals and restricts access to certain operations per the individual’s assigned role.
  • Sprint mD can be configured to have passwords expire. The Sprint mD goes even further by providing optional administrative best practices to enforce password content requirements and password policies, such as minimum password length or retry count, etc.

Safety and Efficiency

Title 21 CFR Part 11 has been in place for more than twenty years, however, advancements and innovation, combined with the volume of data being generated makes the regulation more relevant than ever for medical device manufacturers. When testing life-saving medical devices, there’s no room for error. Uson’s Sprint mD makes it possible for medical device manufacturers to move new products into manufacturing quickly while complying with the safety measures put in place by the FDA.

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