Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Vape Shops, Medical Devices, and Translation Review

Posted by crimsonlanguage on 2015/04/09

 I grew up in a small Midwestern town that was once home to a multinational steel producer, the world’s largest dress pattern maker, and hundreds of small machine shops that supplied the assembly lines of Detroit and Chicago. Sadly, those businesses are now all gone, replaced by tattoo parlors, check-cashing services…and vape shops. For those of you that don’t know, a vape shop is where you go to purchase e-cigarettes and supplies.

Now, I have nothing against e-cigarettes and the businesses that sell them per se  (well, maybe a little). However, nearly all e-cigarettes are manufactured in China and, due to a lack of manufacturing quality control, vapor from these products can be tainted with nickel, chromium, silicon fibers, etc. The hazards associated with China-produced e-cigarettes was recently documented in a front-page NYTimes article (you can find it here).

The reason why carcinogenic vape supplies are readily available in the U.S. is largely due to lax manufacturing standards combined with insufficient audit/inspection resources. In this environment, small sub-suppliers are hugely incented to debase products (economic adulteration) –  and you can see this in other examples from China, such as melamine milk and lead paint toys.

This same principle applies to translation services – especially to those in specialized, technical fields like medical device translation. By using less qualified (debased) translators, suppliers lower their costs and improve margins. Similarly, cutting back on necessary QC processes has the same beneficial effect for suppliers, but increased risk and potential long-term cost for manufacturers.  What’s a device maker to do?

Fortunately, Crimson Audit & Review Services can help. Crimson Audit & Review is based on a Notified Body-endorsed audit method, part of the world’s first translation risk management patent, combined with a Notified Body-approved grading and scoring system and validated,  online technology to dramatically increase reviewer convenience and productivity. If your translation review process is out of control, or if you need to protect yourself from potential “economic adulteration” in your translated labeling, Crimson Audit & Review can help. For more information, email: info@crimsonlanguage.com

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Posted in content management, labeling requirments, labeling translation, medical device content management, Medical device marketing translation, post market surveillance, Quality Systems, Risk Management, Supplier Control | Tagged: , , , , , , , , , , , , | Leave a Comment »

Selling Cans of Air & Bottles of Sound

Posted by crimsonlanguage on 2014/07/28

A particularly unvarnished post on the Oxebridge blog caught our attention recently. The author, feeling a bit distressed by claims that ISO 9001:2015 requires “risk management”, solicited opinions from risk management professionals – including authors of ISO 31000 (guidance on risk management). The latest version of ISO 9001 includes language related to risk management in the form of a new and rather ill-defined concept: “risk based thinking”.

According to one respondent to the informal poll, “selling risk based thinking would be like selling cans of air or bottles of sound”.

While the debate in the ISO 9001 community rages on (and it will), it’s important to note that Crimson is well ahead of the curve on this through certification to ISO 14971 – the risk management standard for medical device manufacturers. When you work with Crimson, you can breathe easy – that’s the sweet smell of certified, patented risk management.

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World Cup AND Medical Device Regulatory Action Out of Brazil

Posted by crimsonlanguage on 2014/06/28

 

Neymar Flop

          Could it really hurt that badly?

How often will you see those two items in a single headline? I’m just pleased to have a credible excuse to share this hilarious story that appeared in the WSJ on the “World Cup of Flopping” – ranking national teams by their on-field “writhing time”. Not surprisingly, Brazil topped the list, but Chile was a close second. We’ll see who “out-flops” the other in today’s 12:00 match: exciting stuff.

However, very shortly, it just might be U.S. medical device manufacturers who are clocking writhing time in Brazil. Word from a recent Class III client regarding unexpected  ANVISA scrutiny in their registration process is definitely something to cry about: including no longer accepting Portuguese for Portugal (vs. Brazil) in labeling. Ouch!

The written forms of these two languages are mutually intelligible – a Brazilian can read in Portugal and vice versa – but there are significant spelling and grammar differences – and now, evidently, this has become a point of regulatory enforcement for ANVISA…and manufacturers selling into Brazil.

If you have direct experience of tightening ANVISA requirements, post and comment and let us know! – thanks.

Posted in 510K submission, Competent Authorities, export requirements, labeling requirments, labeling translation, medical device industry news, Regulatory, Uncategorized | Tagged: , , , , , , , , , | Leave a Comment »

Don’t Get Yanukovych’ed

Posted by crimsonlanguage on 2014/03/05

Good post on the perils of language nationalism on the EnCompass  “Blood Makes Noise” blog.

Moral of the story: know your market before you make your language selections.

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Placebo Surgery Raises Effectiveness Questions

Posted by crimsonlanguage on 2013/12/26

In a surprising Finnish study, a fake (placebo) surgical procedure was shown to be as good as real surgery at reducing pain associated with a torn meniscus. The full story in the WSJ is available here.

Beyond the surprise and interest factor of the study, it also points to the ongoing interest in comparative effectiveness research. Device makers should be prepared to demonstrate effectiveness of their products – even if, historically, it hasn’t been questioned. Said Teppo Järvinen, one of the studies authors, “Doctors have a bad tendency to confuse what they believe with what they know.”

 

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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”.

Posted in labeling requirments, labeling translation, Risk Management, Supplier Control | Tagged: , , , , | Leave a Comment »

Medical Device Tax Will Remain in Play for Debt Ceiling Negotiations

Posted by crimsonlanguage on 2013/10/16

med-device-map

If you wonder why the medical device tax has emerged as a debt-ceiling-negotiation hot topic, take a quick read of this Washington Post Wonkblog post.

At this point, the best that anyone’s hoping for from the current debt ceiling negotiations is a delay – a temporary increase in borrowing power until after the New Year when all the crazy madness starts all over again.  So, even if the device tax is off the table for now, don’t count it out in the long-term. There is real bi-partisan support (how often do you see Elizabeth Warren and House Republicans aligned?) to repeal this ill-designed tax.

Posted in Forecasts, industry employment, medical device industry news | Tagged: , , , , | Leave a Comment »

Government Shutdown Resolved by Device Industry?

Posted by crimsonlanguage on 2013/10/03

erik_paulsen_640We’re currently at day three of the US government shutdown – besides FDA speakers unable to address industry representatives at this week’s RAPS conference, 800,000 government workers are dealing with painful furloughs.

Amidst all the Republican vs. Democrat name-calling, Representative Erik Paulsen (R, Minnesota) said during an interview with a major news outlet: “The medical device tax is a linchpin” that could help save the current shutdown negotiations. The logic here is that a repeal of the device tax is small enough that it wouldn’t affect the Affordable Health Care’s overall viability, but would allow the Republicans to claim some measure of face-saving victory (personal note here – Paulsen’s collaborator on the repeal is Ron Kind, another Wisconsin rep and friend of mine from college).

Fingers crossed here – while I do believe in affordable healthcare for everyone, I also happen to think that the device tax is ill-conceived.

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FDA Sends Nonessential Speakers to RAPS

Posted by crimsonlanguage on 2013/10/01

nonessential

Attendees at this year’s RAPS conference were treated to cancelled meetings thanks to the government shutdown. Evidently, some FDA officials were considered “nonessential” and therefore not permitted to speak…the upcoming session with Dr. Shuren is still planned…I guess the Director *is* essential.

Check back for more info from the conference over the next few days.

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Device Industry Aghast Over Proposed EU PMA Regulation

Posted by crimsonlanguage on 2013/09/26

On September 25th, a EU Parliament committee voted on proposed reforms to the device approval process – the results weren’t pretty for industry. Rather than the initial proposal to tighten control of Notified Bodies and begin unannounced facility inspections, the committee voted in favor of a centralized premarket approval process for high risk devices…similar to the U.S. system. A good overview is available at FierceMedicalDevices.

Not surprisingly, industry (including AdvaMed and Eucomed) are seriously concerned about approval delays that could harm manufacturers’ competitiveness…along with the ability of the EMA to manage the effort.

Stay tuned to this one – could be a significant change for EU device sales.

Posted in medical device industry news, Regulatory | Tagged: , , | Leave a Comment »