Over 40 Auriga Engineers Received Certificates of Training in IEC 62304

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Over 40 Auriga Engineers Received Certificates of Training in IEC 62304

July 22, 2013

Medical equipment software development is one of Auriga’s main areas of activity. For over 10 years, Auriga has been providing a wide range of services, from software lifecycle processes to medical OEMs. During this time, we have accumulated considerable experience in the development of life-support and monitoring systems (bedside monitors, artificial lung ventilation apparatuses, etc.), including those for intensive care units. Along with software development, Auriga’s highly skilled professionals carry out testing, verification, and validation of software products and provide technical support at all stages of the software lifecycle.

Auriga’s success in this regard is confirmed by independent experts. Six years in a row, Auriga has been included in the Best 10 Rising Stars by Industry Focus – Health Care Sub-list in the Global Outsourcing 100 list by the International Association of Outsourcing Professionals® (IAOP®).

The medical equipment market continues to grow. According to a report from EvaluatePharma, the global medical device market will reach $440 billion by 2018, growing at about 4.4% per year. Once again, this confirms the extremely competitive nature of this market and the demand to continuously improve existing systems and develop new ones. The increasing complexity of medical technologies requires Auriga’s engineers to understand the specifics of medical software development standards and to be able to put them into practice.

At Auriga, we maximize our training efficiency and conduct in-house training sessions for these standards for engineers working on relevant projects. As a result of this, we can guarantee the medical equipment Auriga works on complies with generally accepted global standards (i.e., FDA 21 CFR Part 820, ISO 13485, IEC 60601-1-8, and IEC 62304).

In addition to the in-house training sessions, in June, additional training sessions were conducted for the international standard IEC 62304 (medical device software development) in the Moscow and Nizhny Novgorod development centers. The training was run by the Swedish company SYNERGUS, which is certified to conduct such training courses and has the right to issue official certificates. In both cities, Robert Ginsberg, VP Quality and Regulatory, SYNERGUS, conducted two-day training sessions, with over 40 Auriga engineers participating in the course and receiving international certificates after completion.

This training was designed to help Auriga’s engineers to organize the information they have about IEC 62304. An additional series of training sessions conducted by one of Auriga’s customers—a global leader in medical devices and software development—helped to solidify the gained knowledge.

Auriga pays special attention to the training of its employees and plans to further extend the training program to ensure maximum compliance with all the industry standards that govern software development for medical devices.

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