The Importance of ISO Certifications for High-Quality Medical Translations
Medical translations are a specialization that require high-quality work. There is zero tolerance for error — even a missing decimal point on a document could cause harm or death. That’s why it is absolutely critical to work with a medical translation company certified to the latest ISO standards. Applying for these certifications is voluntary and time-consuming, not to mention expensive, so not every translation company chooses to complete the process. Those that do are providing you with a signed commitment to delivering first-rate products/services, and that should give you confidence in the company. Now let’s take a look at three ISO standards that a medical translation company should have and the value that they bring.
Three Key ISO Certifications
A translation company that specializes in medical document translations (e.g. clinical trial documents, regulatory submissions, or labeling & instructions) should have the following ISO certifications:
- ISO 9001:2015 – This is an internationally recognized standard that outlines general processes and procedures for maintaining a quality management system (QMS). It applies to any business in any industry.
- ISO 17100:2015 – This standard is intended specifically for translation service providers. It outlines specific processes, resource requirements and other stringent guidelines for the delivery of high-quality translation services.
- ISO 13485:2016 – This standard defines the requirements of a QMS for companies that are in the medical device industry. It outlines obligations for manufacturers and service providers to monitor and control both internal processes and outsourced processes that affect product quality. This is where translation and localization companies come in – if a medical device manufacturer outsources their translation process, the manufacturer must be accountable for their supplier. Thus, many large medical companies will also require their translation company to have achieved ISO 13485:2016 certification.
What is a QMS?
A QMS is a formalized quality management system that documents processes, procedures and responsibilities for meeting quality objectives. A QMS provides many benefits, including improved processes, reduced waste, reduced costs, and optimized resources. In addition, a QMS directs a company in how to best achieve customer requirements. To obtain ISO certifications, and to get re-certified, a company must have good management and quality practices.
A Deep Commitment to Clients in the Medical Industry
Obtaining the three ISO certifications above, especially ISO 13485:2016, shows that a company is deeply committed to serving the medical device market. To obtain the certifications, a company must meet the strict requirements of the standard, go through a rigorous auditing process and become re-certified on a routine basis. It’s a laborious process that requires significant resources and regular maintenance. It’s also a voluntary process, so a company that obtains these certifications shows a true commitment to quality control.
Translation Tools and Technologies Drive Efficiency
As part of their QMS, a translation company should have professional translation tools and technologies such as:
- Translation memory (TM) – A translation memory is a repository of original content and the translated versions of that content. A TM reduces costs, increases consistency and reduces time to market.
- Terminology management and glossary tools – These tools manage client-specific terminology, including branded terms, products/services and industry terms. Managing terminology helps to maintain consistency across translations, while simultaneously reducing costs and time to market.
- Client Platforms – A client portal (or platform) is a tool for clients to access and manage their translation projects at any time. Portals usually have features such as initiating and tracking projects, communicating with team members and downloading reports.
These types of tools drive process efficiency and bring numerous benefits to clients and the company.
At Morningside, we’ve been providing high-quality medical translation services for over 20 years and we have obtained all three of the critical ISO certifications described above. Our quality assurance process includes many layers of controls, including editing and proofing with built-in redundancies. To learn more about our high-quality translations, contact us today.
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IP Hot Topics for 2020
2019 was a big year in IP, with major developments in technologies like AI and Big Data that will impact IP law and policy for years to come, and U.S. federal courts sending mixed signals on patent rights in several important rulings. So as we begin 2020, let’s take a closer look at three topics that we predict will be hotly debated by IP practitioners and policy makers this year:
IP hits the road with 5G
A key element in the eventual arrival of fully autonomous vehicles will be the 5G technology that allows a car, truck or bus to remain in continuous communication with the smart road on which it travels, with other vehicles, and with a ubiquitous navigation infrastructure. Meet “vehicle-to-everything,” or V2X, communication.
It will be a lightning-fast communication system in which the roads themselves broadcast current conditions so that vehicles can prepare and respond to potential hazards. One of the current roadblocks to self-driving vehicles — up-to-the-minute, accurate digital maps — will be overcome by navigation streamed from satellite-borne systems. Vehicle-to-vehicle communication should, ultimately, reduce collisions and traffic jams.
Each piece of this interconnected puzzle is likely to be controlled by proprietary software. To make travel safe and trouble-free, the quality of these applications will be paramount and will represent a tremendous licensing opportunity for owners of the most robust and reliable software solutions.
Right now, however, there are lots of unanswered questions. Who will coordinate, purchase and maintain all of the puzzle pieces? Private businesses? Municipal, state, or federal governments? And, will governments finally become more responsive to the needs of software IP holders?
Ecommerce & the evolution of counterfeit goods
According to a 2019 NPR/Marist poll, 76% of U.S. adults (aged 18+) shop online at least once a year – and 25% of those surveyed made monthly online purchases. Clearly, buyers love the benefits of shopping online: there’s no need for travel, it’s easy to find cost comparisons and product reviews, and there are just so many choices! But that’s actually part of a growing problem.
The tremendous growth of ecommerce has provided a lucrative playing field for the sale of counterfeit goods in the United States. According to the U.S. General Accounting Office (GAO), approximately $1 billion in fake products is sold online every day. As part of their research, the GAO purchased a number of name-brand merchandise pieces online — including Nike Air Jordans, Yeti travel mugs and Urban Decay cosmetics — and found that 43% of them were fake.
Tania Clark of the Chartered Institute of Trademark Attorneys tells Raconteur, “Those selling fake goods are very innovative. They often try to escape censorship by copying a logo, but not the brand.” These products steal value from genuine brands, adding insult to financial injury.
Policing the theft of intellectual property by bootleggers is a non-stop international game of whack-a-mole that’s a headache, and expensive, for IP holders and ecommerce platforms alike.
Clark says, however, that a sense of partnership between IP holders and retailers is starting to emerge. “Our clients, who range from small businesses to multinationals, are telling us that thanks to a collaborative approach around IP protection involving both brands and the ecommerce platforms, it’s becoming much harder for counterfeiters to flourish.”
Amazon, for one, released Project Zero earlier this year – a machine learning program that continuously scans Amazon stores and proactively removes suspected counterfeit products. Project Zero also contains a self-service counterfeit removal option for authorized brands, which means they no longer need to file a report with Amazon and wait for an answer. Alibaba also has a program in place to take down fake listings within 24 hours. We expect and hope to see a growing shared commitment to fighting bootlegging between IP holders and ecommerce platforms in 2020.
Is software finally getting its IP due?
When it comes to intellectual property protection, computer software was late to the party. The concepts underlying IP, after all, date back almost 300 years, long before even the concept of software existed. The general thinking, says WIPO, is that “computer programs should be protected by copyright, whereas apparatus using computer software or software-related inventions should be protected by patent.”
Even with copyrights, however, there remain significant unknowns and contradictions. Using the U.S. as an example, Section 102(b) of copyright law states: “In no case does copyright protection for an original work of authorship extend to any idea, procedure, process, system, method of operation, concept, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or embodied in such work.” This list almost perfectly describes software.
A dispute coming before the U.S. Supreme Court now, however, may help clarify things. At issue is the multi billion-dollar claim by Oracle that Google copied 11,500 lines of computer code from Oracle’s Java application programming interface (API) and incorporated it in Google software. Oracle asserts this action infringes on and devalues the company’s copyright of Java. A Federal Circuit court agreed, but Google has successfully petitioned the Supreme Court to revisit that ruling.
While this is by no means a universally lauded decision, it nonetheless provides the Court an opportunity to clearly rule on two key IP questions: (1) Can a software interface be copyrighted? (2) Does the incorporation of copyrighted software into new software constitute fair use?
Obviously, if computer software isn’t copyrightable, then Oracle has no right to seek restitution or remedy, and the Supreme Court would be on record as definitively stating that software is not copyrightable. The fair use question is secondary, and it remains to be seen if the Supreme Court will be able to provide universally applicable guidance on the fair use of software. It’s also possible that the ruling will be confined to the specifics of this case, and thus less helpful as precedent. Either way, it’s a case well worth watching; Dennis Crouch on PatentlyO said it could be “the biggest patent case of the year” in 2020.