Applying for a Patent in Germany
Did you know that Germany is now ranked as the most innovative nation worldwide? Bloomberg reports it’s a thriving European center for innovation where patent activity, high-tech density, and value-added manufacturing are on the rise.
If you wish to join the trend and patent your innovation in Germany, it’s critical that you understand how the the German patent application process works. For example, did you know that filing your patent application with the German Patent and Trademark Office secures your priority date – but it does not begin the official examination required to grant the patent?
Learn more about the filing and examination process in Germany by viewing our most recent article on IPWatchdog. There, we cover:
- German patent filing methods
- How to begin examination in Germany
- Germany’s language requirement
- The difference between German patents and utility models
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5 Tips on Translating Medical Device Labeling
Regulatory authorities around the globe view medical device labeling as an integral part of the medical product itself. These documents provide critical risk/benefit information as well as clear instructions for safe use. They come in a wide range of formats, including brochures, leaflets, user manuals and videos – basically, any document containing explanatory information geared toward the patient.
When a medical device is introduced to a new market, all labeling content is carefully reviewed for compliance with local rules and regulations. Any problems with the way the labeling is worded could result in a delay in distribution, a product recall or adverse events with patients. That’s why it’s critical that these documents – and all medical translations of them – are as accurate as possible from the beginning. So, check out the following five tips to learn more about overcoming multilingual issues in medical device labeling.
Tip #1: Use accessible language
The efficacy and safety of a medical device is dependent on proper usage. Be sure to avoid jargon and keep instructions simple. Not only will this kind of language make it easier for English-speakers to understand, it will also make it easier to translate medical labels into the other languages required.
Tip #2: Provide documentation electronically
Some regulatory authorities require medical device labeling to be provided online, and it should be clear to the end-user where that information can be accessed. Digital deployment makes it easier to provide labeling in multiple languages without adding bulky documentation to the device packaging. It also makes it easier to keep information up-to-date.
Tip #3: Use graphics liberally
Medical device labeling is a classic case where a picture is worth a thousand words when incorporated effectively. Try making graphics large enough to convey the focal point. Use dark, sharp lines for good contrast, and add cues such as circles or arrows to highlight key information.
Tip #4: Use internationally recognized symbols and icons
Many symbols and icons have become standardized and should be used wherever possible in medical device labeling to overcome language barriers. However, it is incumbent on the manufacturer to ensure that the symbols and icons will be properly understood by any given target audience – which is why pretesting and localizing of medical labeling content is critical.
Tip #5: Use videos or animations
Supplement classic instruction manuals with engaging videos or animations that contain minimal text and maximum imagery.
Start early, finish ahead
The complicated process of medical device labeling is easier to manage if its multilingual components are addressed strategically from the beginning. Clearly translated medical content and a rich array of graphical elements will ensure that the labeling makes sense across a wide range of target languages. If you need help translating your medical device labeling, reach out to Morningside below. Our team has in-depth industry knowledge of country-specific regulations, global markets, and the entire life sciences commercial supply chain.
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Translation Quality Standards – What Do They Mean?
According to the International Organization for Standardization (ISO), quality can be defined as “the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.” In the case of translation, quality can be defined as the success of the translation in accurately capturing and conveying the information and intent of the source document.
Translation quality becomes mission-critical in domains such as IP, medical, legal, accounting, and technical documentation, where poor-quality translations could cause loss of business value and, in some cases, even loss of life.
What is an ISO Standard?
ISO standards set out various business processes and best practices that are internationally agreed by experts. ISO standards for translation quality focus on establishing and maintaining a process of translation, review and approval that, when followed diligently by qualified professionals, will consistently result in translations that meet customer expectations.
Two Examples of ISO Quality Standards
ISO 9001:2015 is the world’s most widely recognized quality management standard. ISO 9001 outlines ways to achieve consistent performance and service at all levels. Achieving this certification means a company has created a quality system with a framework for better customer satisfaction, staff motivation and continuous improvement.
ISO 17100:2015 is an international quality standard set specifically for the translation industry. It defines the requirements for the core processes, resources and other aspects necessary for the delivery of a quality translation service. Certification to ISO 17100 showcases a translation company’s high level of commitment to meeting client and industry requirements.
Industry-Specific Translation Quality Standards: A Medical Example
Some industries have specific translation quality needs that cannot be met by more generalized quality standards. A good example is ISO 13485:2016, which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 can also be used by suppliers or external parties that provide products or services to such organizations.
Language service providers (LSPs) like Morningside that are certified to ISO 13485 collaborate with medical device companies to determine risk management for all of its medical device translations. With the LSP implementing processes that reduce the potential for product risks, the medical device company reduces its exposure to compliance and legal issues, not to mention risk to customers.
International Standard for Security Management
ISO 27001:2013 is an extensive framework of requirements for “establishing, implementing, maintaining and continually improving an information security management system.” It ensures that business information is handled in a confidential and secure manner, and that appropriate care is taken to mitigate risks that could potentially compromise the integrity of client data.
Morningside is the first major patent translation and filing company in the world to obtain this certification, and one of only a handful of language service providers (LSPs) to have achieved it. Achieving this prestigious certification is no small feat and demonstrates complete commitment to client data, systems, and processes.
At the end of the day, it’s all about the people and the process
Translation quality standards play an important role but they are no substitute for providing ongoing training and feedback to translators, as well as arming translators and editors with the necessary resources and information on the subject matter, context in which the translation will be used, etc. Translation teams who are equipped with glossaries, style guides, support materials, and contextual information can produce a translation of much higher quality than those who are just handed a text with no background.