Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

BSI Warns on ISO 14971 Compliance Risks – Crimson Provides Labeling Support

Posted by crimsonlanguage on 2013/11/01

BSI recently pointed out the four (4) biggest compliance problems that US device makers have with ISO 14971:

1.  Failure do design out risk

2.  Failure to conduct risk-benefit for each item and overall product

3.  Failure to demonstrate device risk reduced to “as low as reasonably practicable”

4.  Using warnings section as catch-all for unmitigated residual risk

Interestingly, items 3 and 4 are directly relevant for translated labeling:

Reduce risk “as low as reasonably practicable” (item #3) – since, by definition, labeling is a component of your device, it is critically important that the error risk of translated labeling is “as low as reasonably practicable”. This is where Crimson’s patented, ISO 14971-registered, risk management process can play an important role for manufacturers looking to improve the quality of translated labeling or demonstrate compliance with the requirements of the standard. Crimson is the only supplier to hold a Notified Body endorsement for audit of legacy labeling translations, we see a lot of work from other suppliers, so we know that our process reduces risk by up to four times over standard translation processes.

Using warnings section as residual risk “catch all” (item #4) – a device IFU is a risk mitigation and the warnings section is generally the highest risk section of the IFU. The content that companies commit to the warnings section should be handled by a “state of the art” risk managment process. This is exactly what’s defined under Crimson’s patented labeling translation risk management process (U.S. Patent No. 8,140,322 B2).

Any way you look at it, risk management is becoming more and more important for medical device manufacturers worldwide. Working with an ISO 14971-certified supplier (like Crimson) helps you to manage risk and ensure that it has been reduced “as low as reasonably practicable”.


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