The Pioneer of Modern Leak Testing

FDA Title 21 CFT Part 11 ComplianceStreamlining FDA Compliance for Medical Device Manufacturing Applications


How Uson’s Sprint mD and Optima vT are making FDA Compliance Easier 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 streamlining FDA compliance for medical device manufacturing applications.

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 Sprint mD and Optima vT leak testers.  Part 11 defines the criteria under which electronic records and electronic signatures are considered equivalent to paper records. 

Meeting FDA Compliance Objectives Through Medical Device Manufacturing 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 & Optima vT Leak Testers

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. The Sprint mD and Optima vT easily support all three requirements, optimizing the testing process so the devices can more quickly enter the medical industry.

Features that support the requirements include:

  • User name and password combination requirement 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.
  • Passwords expiration configuration options, in addition to optional administrative best practices to enforce password content requirements and password policies, such as minimum password length or retry count, etc.

Safe & Efficient Leak Testing

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 and Optima vT make 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.

Have Questions? We Can Help!

If you have questions regarding how the Sprint mD and Optima vT leak testers can help simplify FDA compliance for your medical device manufacturing application, the team at Uson can help. Click here to find your local Uson representative, call us at +1-281-671-2000 or click here to contact us via email.

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21 CFR Part 11 - Sprint mD & Optima vTUson’s Sprint mD and Optima vT leak testers are designed to help medical device manufacturers comply with 21 CFR Part 11

Download our whitepaper for details about how the Sprint mD and Optima vT leak testers help medical device manufacturers comply with Title 21 CFR Part 11.


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