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How to pass ISO 13485 Lead Implementer Exam

Proper and safe function of all medical devices can save thousands of lives, and can improve our health on the long run, but if safety and quality measures are not implemented effectively, medical devices can also cause huge damages. The main purpose of the ISO 13485 Quality Management System is to minimize risk to the end-users of medical devices through interrelated processes that cover all aspects of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of medical devices, design and development, or provision of associated activities such as technical support.

Therefore, to pass the ISO 13485 Lead Implementer exam successfully, the candidate needs to pay extra attention to the following:

  • Make sure you understand well the clauses of the standard and their application, by relating them to your daily decision-making processes. Concentrate more on methods and techniques in the implementation of the Medical Devices standard based on ISO 13485.
  • Recognize the main purposes of implementing Quality Management System for Medical Devices within your organization, while integrating the organization’s objectives with the ISO 13485.
  • Determine what would best suit your organization’s current needs, by helping your organization to increase company’s reputation as well as identifying best practices based on the ISO 13485.
  • Understand the basic principles of the ISO 13485:2016, and focus on requirements that impact daily basis operations of the organization in the Medical Device industry.
  • Pay attention to risk, by putting more emphasis on how risk would be managed effectively throughout the life cycle process of the medical devices, including outsourcing.

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