Part 2 -The Risk of Non-Compliance to Medical Device Manufacturers.

What medical device manufacturers can do to avoid financial risks associated with non-compliance.

Ongoing regulatory compliance heavily impacts the development, launch, and manufacture of medical device products. Because of the highly regulated nature of this industry, manufacturers face a regulatory process that is lengthy and unpredictable and can impact whether a product is approved for the market. The risks of non-compliance to medical device manufacturers are steep, and can impact their profitability.

The risk of non-compliance can have a major impact on medical device manufacturers.

Revalidation efforts can be extensive

When it comes to medical devices, quality control is of the utmost importance. A bad part must never leave the facility, and the process to ensure that must meet FDA standards. There can be a delay in FDA approval due to lack of compliance, if the process doesn’t meet FDA standards.

Ideally, you want to start with equipment that complies with 21 CFR part 11 standards, because it is very expensive to upgrade non-compliant equipment. Additionally, you should select a leak tester manufacturer with decades of experience in the manufacture of leak testers, combined with a deep understanding of the medical device industry – both in the R&D and manufacturing sectors. Only a highly experienced leak tester manufacturer is equipped to deliver a leak tester that is specifically calibrated to meet the range of needs of a complex process.

The cost of non-compliance can be very high.

Non-compliance with 21 CFR 11 – and other similar regulations – can lead to losing your certificate of compliance, which puts a hard stop on manufacturing and leads to a loss in profits. 21 CFR 11 requirements cover areas like validation, authorization, audit trails, record retention, record copying, traceability, and reporting, among others.

In the past, compliance could be achieved with a simple key switch on a leak tester. Today, stricter requirements require leak testers to offer more sophisticated solutions, such as:

• Customizable user authentication using individual passwords and roles
• Ability to log and monitor changes to parameters to achieve compliance
• Refined analytics that allow users to identify historical trends and catch process degradation before it becomes a problem
• Reduce transcription errors through automated tracking
• Built-in data collection, archiving, & reporting
• Built-in fieldbus capabilities for two-way communication

Uson’s Sprint mD and Optima vT leak testers help users achieve a new level of compliance with features such as user authentication, individual passwords, the ability to log and monitor changes, historical data tracking and reporting, and fieldbus compatibility.

This article is part 2 of a 3-part series: