ISO 13485 Lead Implementer

ISO 13485 Lead Implementer (PECB)

 

За Курса (About this Course):

    • ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.

      After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

Цели – Какво ще научите (Course Goals/Skills):

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

Формат на курса (Course Format):

Присъствен (Classroom) Курс в Учебната ни зала или В Офис на Клиент

Онлайн (Online/Virtual) Курс във виртуална зала с инструктор

Език на курса (Course Language Option)

Български (Bulgarian)

Английски (English)

Може да изберете Език на който да се проведе обучението – български или английски. Всичките ни инструктори владеят свободно английски език.

Учебни Материали (Student Guides):


 

Учебните материали са достъпни в електронен формат. Могат да се ползват online/offline на всяко устройство. Доживотен достъп.

Лабораторна среда (Lab Environment):

Всеки курсист разполага със собствена лаб среда, където се провеждат упражненията, част от курса. Не е необходимо да инсталирате софтуер на компютър или специални изисквания за хардуер.

Участниците в присъствен формат в Учебния ни център разполагат с индивидуален компютър по време на обучението.

След завършване получавате (At Course Completion):

Lifetime Access - Video Archive 24/7

Certificate of Course Completion

Доживотен достъп до видео архив с запис на всяка отделна лекция.

Официален международно признат сертификат за завършен курс на обучение.

Продължителност (Course Duration):

  • 5 работни дни (09:00 – 17:00)

или

  • 40 уч.ч. обучение (теория и практика) в извънработно време с продължителност 4 седмици
  • събота и неделя 10:00 – 14:00, 14:00 – 18:00, 18:00 – 22:00
  • понеделник и сряда 19:00 – 23:00
  • вторник и четвъртък 19:00 – 23:00

Плащане

 

Заявка за издаване на фактура се приема към момента на записването на съответния курс.

Фактура се издава в рамките на 7 дни от потвърждаване на плащането.

Предстоящи Курсове

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