Factors to Consider For Your e-Labeling Translation and Publishing Compliance Process

The EU Commission Regulation 207/2012 on electronic labeling of medical devices allows manufacturers of certain type of medical devices and accessories to provide electronic .
 
NEW YORK - June 29, 2013 - PRLog -- The EU Commission Regulation 207/2012 on electronic labeling of medical devices allows manufacturers of certain type of medical devices and accessories to provide electronic instructions for use (IFU) in order to achieve the requirements of the Medical Devices Directive (http://www.merrillbrink.com/medical-device-and-diagnostic-translation.htm). E-labeling can be applied on products that fall under the regulation, such as active implantable devices and their accessories, installed devices and devices and accessories with a built-in system visually displaying instructions, or standalone software.

Manufacturers should perform a detailed, documented risk assessment to identify any areas of potential risk and any additional investment required to achieve compliance. It is important to assess the impact of this regulation on your business as it affects content matter management, translation procedures, review and approval, as well as quality control procedures. Internally, an audit can be done to assess the cost-benefit analysis of e-labeling, plus an evaluation of the current translation and publishing process for IFU information.

The main factors to consider in the e-labeling translation compliance process are people, process and technology. Here are just a few questions that you should consider in your internal assessment process:

·         People - Do you have external and internal resources necessary to manage this process? Does it make sense to add internal resources, outsource certain functions, or both?

·         Process - Does your language translation partner employ best practices such as LEAN business process tools or Six Sigma methodologies to ensure that the highest levels of quality are being maintained on your projects? If so, what levels of certification have they achieved?

·         Technology - Is your current publishing platform capable of producing IFUs in print (http://www.merrillbrink.com/ifus-translation.htm) and electronic formats? If not, does your language translation partner offer additional production and publishing services?

Keep in mind that the goal of the regulation the e-IFU is to make it more convenient and efficient to the end user.  To learn more about how translation affects marketing your device in Europe and how these new Regulations affect your device, read the full article at http://www.merrillbrink.com/factors-that-will-help-audit-your-translation-process-for-elabeling-06242013.htm.

About Merrill Brink International

Merrill Brink International (www.merrillbrink.com) is a leading provider of complete translation and language solutions for global companies and law firms, with special expertise in serving the legal, financial, life sciences, software, heavy machinery and corporate markets. A proven leader with more than 30 years of experience, Merrill Brink offers a wide range of language solutions including translation, localization, desktop publishing and globalization services.

Merrill Brink is recognized in the industry for its commitment to quality and its pioneering approach of leveraging technology to reduce costs, eliminate redundant processes and accelerate translation life cycles. Merrill Brink is certified to ISO 9001:2008; ISO 27001:2005 and ISO 13485:2003, and registered to EN 15038:2006 and ISO 14971:2007. Together, these standards provide assurance that the most stringent process and quality standards for translation are followed. Merrill Brink International is a wholly owned subsidiary of Merrill Corporation.
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