Working with an ISO 14971 Compliant Translation Company
Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an 'important outsourced service'…This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971. - KEMA
ISO 14971-2007 at a Glance
First, let's define what the ISO 14971 standard specifies. According to the International Organization for Standardization (ISO), "ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life cycle of a medical device." The translation of labeling literature, which conveys critical information about the device, is now considered by most Notified Bodies as a key activity in the life cycle of a device. The ability for a translation provider to assess and mitigate issues inherent to the translation of labeling and product information, and to incorporate it in its quality system, aligning it with the quality system of the device manufacturer, is key in this regard.
Risk Assessment, Risk Mitigation, and Risk Management
ISO 14971 is all about risk management. When working with an ISO 14971- compliant Translation Service Provider, the risks involved in the translation of labeling, software and device documentation will be thoroughly assessed and addressed in a comprehensive and adequate manner, and will be integrated in the quality system of the translation supplier. Device manufacturers can be certain that the language-related risks associated with marketing their products overseas will be acknowledged and mitigated.
Just like the hazards associated with manufacturing medical devices –and the English documents and software that accompany them –translations are never without some level of risk. Doing business with an ISO 14971-compliant Translation Service Provider offers the assurance that a structured discipline is in place to ensure that risk is minimized. It confirms the TSP's commitment and involvement in the risk management process. In addition, it provides an excellent risk management model that focuses on the entire life-cycle of translations.
Satisfaction for all Stakeholders
Device manufacturers will know that the same systematic attention and resources they apply to identify, assess, evaluate and control risks associated with their products are applied to the translations that are required to market them overseas.
This "peace of mind" will be shared not only by device manufacturers and their purchasing, quality and regulatory departments but by all stakeholders in the process: patients, operators, medical practitioners, distributors, regulatory agencies and notified bodies.
Note: The 14971 Risk Management Standard is recognized by the EU, Health Canada, Japan and the FDA.
