Category Archives: What’s New

Idem Translations Achieves EN15038:2006 Certification

Firm follows the best practices model designed exclusively for the translation industry

Palo Alto, California, January 29, 2013 – Idem Translations, Inc., a full-service provider of translation and localization services, has achieved EN 15038:2006 certification from TÜV SÜD America Inc., a worldwide certification body for quality management systems. The company’s quality management system is additionally certified to the ISO 9001:2008 and ISO 13485:2003 international standards.

This achievement makes Idem Translations one of a select group of language service providers to hold all three industry certifications for the translation of life sciences materials.

EN 15038:2006 was developed by the European Committee for Standards (CEN) to establish and define the requirements for the provision of quality services by translation service providers. The standard encompasses the core translation process, including commissioning, translation, proofreading, review, project management, quality control, traceability, and delivery. It helps describe and define the entire service and offers a set of best practices for all aspects of the translation and localization process.

Idem provides expert translations of all types of documentation related to research and development, clinical trials, FDA and CE Mark submissions, international marketing, and ongoing patient care.

“The best practices outlined in EN 15038 set the industry standard for the highest quality language services,” said Mariam Nayiny, president of Idem Translations, Inc. “Idem’s certification to this standard confirms that our audited procedures are designed to consistently produce the quality results expected by our life sciences clientele.”

“Achieving EN 15038 certification demonstrates that a translation service provider has successfully implemented the processes considered necessary to ensure quality translation, including traceability of linguistic resources and the specialized professional competencies required of translators,” said Charles Clark, technical product development manager, Management Services of TÜV SÜD America Inc.

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Idem Translations Achieves ISO 13485:2003 Certification

Firm holds specific quality certification for the translation of Life Sciences materials

Palo Alto, California, January 24, 2013 – Idem Translations, Inc., a full-service provider of translation and localization services, has achieved ISO 13485:2003 certification from TÜV SÜD America Inc., a worldwide certification body for quality management systems. The company’s quality management system is additionally certified to the ISO 9001:2008 and EN15038:2006 international standards.

This achievement makes Idem Translations one of a select group of language service providers to hold all three industry certifications for the translation of life sciences materials.

ISO 13485:2003 is a globally recognized standard developed by the International Organization for Standardization (ISO) that specifies the requirements for quality management systems (QMS) in the medical device industry. In order to be certified to the ISO 13485:2003 standard, companies must demonstrate the implementation, maintenance, and effectiveness of a medical device QMS that identifies, manages, and minimizes risks associated with the manufacturing of medical devices and related services.

Idem provides expert translations of all types of documentation related to research and development, clinical trials, FDA and CE Mark submissions, international marketing, and ongoing patient care.

“ISO 13485:2003 distinguishes Idem from other language service providers because it demonstrates our understanding of the regulatory environment in which our clients operate,” said Mariam Nayiny, president of Idem Translations, Inc. “By meeting the same rigorous requirements to which our medical device clientele adhere, we are uniquely able to manage risk and maintain effective processes for their benefit.”

“Achieving ISO 13485:2003 certification exhibits Idem’s commitment to quality,” said Craig Casillas, vice president, Management Services, TÜV SÜD America Inc. “It demonstrates companywide dedication and teamwork to continually monitor quality and consistently follow well-organized processes.”

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Idem Announces Winner of ACRP 2010 Global Conference and Exhibition Raffle

As a sponsor of the ACRP 2010 Global Conference and Exhibition Idem raffled a full conference pass valued at $1,199 dollars for the event which took take place April 23-27th in Tampa.  We are proud to announce that the pass was awarded to Chris Cain, VP of Clinical Affairs from PAVAD Medical. Congratulations Chris!

One of the main learning objectives of this year’s conference was to identify the implications for global clinical research, such as recruitment efforts within special populations, consenting vulnerable populations and regional regulatory and legal issues. As a leader in certified translations for the Life Science community, Idem feels it is important to support this critical industry event. We enjoyed attending the event and interacting with industry leaders.

Pictured below: Nancy Kellen next to the recognition of bronze sponsors at entrace of exhibit hall.

About Association of Clinical Research Professionals
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded in 1976 to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 30 years later, ACRP is a global association comprised of more than 20,000 individuals in over 60 countries dedicated to clinical research and development. Our mission: To provide global leadership to promote integrity and excellence for the clinical research profession.
For more information visit: www.acrpnet.org.

Idem Supports Doctors Without Borders’ Haiti Earthquake Response

January 14, 2010 – In response to the tragedy faced by those affected by the 7.0-magnitude earthquake that struck Haiti on Tuesday, Idem has donated funds to the Haiti Earthquake Response by Doctors Without Borders. They will provide medical care for the men, women, and children affected by the earthquake. For further information or to make your own donation, please go to: https://donate.doctorswithoutborders.org.

Idem receives recognition from NCC ACRP

The Northern California Chapter of the Association of Clinical Research Professionals (NCC ACRP) presented Idem with a certificate of recognition at the learning event held on November 5, 2009. Idem has sponsored multiple trainings for the NCC ACRP throughout 2009. This has proven to be a mutually beneficial relationship as the NCC ACRP members are able to reduce the cost of trainings and Idem staff members are also able to attend the trainings and keep current on clinical research topics which are important to life science customers.

The most recent event was held at the Menlo Park VA Auditorium and featured Toby Freedman’s presentation on current trends in biotech, career planning and development approaches for 2010. At the end of the event, Idem received a special recognition for their ongoing sponsorship efforts. “Idem’s generosity and support of NCC ACRP enables us to bring in speakers like Toby Freedman who focus on a unique aspect of biotechnology, i.e. Career Opportunities & Development. All of our members are extremely appreciative.” – Renisa Satrijo, NCC ACRP Chair, Event Management Committee. In light of the importance of these learning events to the local clinical research professionals and the benefits of being a part of the educational process, Idem has already committed to sponsoring all learning events for 2010.

October 28-31, 2009 – Idem Sponsors the 50th Annual ATA Conference

Again this year, Idem Translations was a proud sponsor of the American Translators Association’s 50th Annual Conference.
The American Translators Association (ATA) is a professional association founded to advance the translation and interpreting professions and foster the professional development of individual translators and interpreters. Its 10,000 members in more than 90 countries include translators, interpreters, teachers, project managers, web and software developers, language company owners, hospitals, universities, and government agencies.
At this year’s conference, Idem planned a presentation in partnership with client Naomi Bear, Director of Microloan Review and Translation at Kiva.org, a non-profit organization providing small loans to entrepreneurs in developing countries. Idem provides pro-bono and at-cost translations for Kiva’s legal documents and due diligence process. Click here for more information.
Pictured below – The Idem sponsored Internet Café at the 50th Annual ATA Conference.

Idem attends Localization World Conference

Idem Translations attended the Localization World conference held in Santa Clara, California. This conference attracted hundreds of localization professionals from around the world
(34 countries to be exact!). The event focused on “Know-how for Global Success” recognizing the fact that localization is not an end in itself, but just one critical step in a company’s progression from domestic to global enterprise.
Idem also took part in the preconference Life Sciences Round Table that discussed Best Practices in localization for the Life Sciences industry. The session allowed Life Science companies (Boston Scientific, Philips Healthcare, St. Jude Medical, CaridianBCT and Zeltiq Aesthetics) and a small group of translation companies to freely exchange information on tools, processes and latest trends in the industry.

Idem receives WBENC Certification

Idem Translations is proud to announce their certification as a Women’s Business Enterprise (WBE), as granted by the Women’s Business Enterprise National Council (WBENC).

“We are excited to be certified by such a prestigious organization as the Women’s Business Enterprise National Council. Idem Translations was founded over 26 years ago, and we are pleased to announce that we are now one of the very few Translation Service Providers that are both ISO 9001:2008 certified and WBENC certified. These certifications are a testament to our commitment to quality and superior customer care,” stated Mariam Nayiny, Idem’s founder and President. “Being certified by the WBENC will allow us to expand into larger organizations, and will provide the opportunity to grow our company to new levels.”

The WBENC is the nation’s leading third-party certifier of women’s business enterprises for the private sector. In partnership with women’s business organizations throughout the United States, WBENC provides access to a national standard of certification and offers information on certified women’s businesses to purchasing managers through its Internet database, WBENCLink. WBENC certification is recognized and accepted by the majority of the major corporations across the United States.

Idem sponsors ACRP Northern California Chapter educational event

IMG_1325 (Custom)Idem Translations was the sponsor of the recent ACRP Northern California Chapter educational event “Medical Device and 510(k) Trials: Audits and Inspections” that was held on September 10. Approximately 102 attendees were able to benefit from this program, which answered many trial-related questions, provided information on how to prepare for possible inspection, and reviewed case studies of audits. Mariam Nayiny, President of Idem Translations, received a Certificate of Appreciation from ACRP. Also pictured below: Marygrace Barasi, Senior Project Manager (center) and Mariam Nayiny (right) chatting with an attendee at Idem’s tabletop display.

Idem passes ISO re-certification and receives ISO 9001:2008 certification upgrade

Idem Translations is proud to announce that the company has passed the re-certification audit with TÜV SÜD America and that the existing certification has been upgraded to ISO 9001:2008. Idem remains one of a few companies offering complete translation and localization services worldwide that is also ISO 9001:2008 certified.

“The ISO certification is important to our clients in regulated industries,” said Mariam Nayiny, President of Idem Translations. “It ensures that their critical documents are translated to meet both stringent regulatory requirements and high quality standards.”

Idem’s original ISO 9001:2000 certification was awarded on August 5, 2003 by the TÜV America, a subsidiary of Group TÜV Süddeutschland, Germany. ISO 9000 is a generic system standard that specifies the necessary components of a quality management system. Rather than being specific to any one industry, it details the basic requirements of the quality function for all industries. ISO 9000’s primary purpose is to provide organizations with useful, internationally recognized models for operating a quality management system. ISO 9001:2008 is the most recent revision of the ISO 9000 standard, which replaces the previous ISO 9000:2000 standard.

For further information about Idem’s ISO certification, please send an e-mail to info@idemtranslations.com or click here.


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