As explicitly stated in Article 10 of the 2017/745 MDR, manufacturers must establish a quality management system that demonstrates evidence that their products and critical processes are identified and controlled. This will be subject to inspection by the Notified Body during the certification processes.

The QMS features defined in MDR Article 10 largely overlap with the ISO 13485:2016 standard requirements, and the Organization is committed to meeting customer and regulatory requirements by adopting the 'process approach' and improving system effectiveness by implementing the Plan, Do, Check, Act or Improve cycle. provides dedication.

The purpose of this training is to inform the participants about the medical device quality management system according to EN ISO 13485:2016 standard requirements. After completing this training, the participants will be able to interpret the EN ISO 13485:2016 standard and quality management systems in a systematic and objective way, and will have the necessary information for audits.

Exhibitor Profile

Employees and managers who will be involved in the work with ISO 13485:2016 standard requirements and who need to better understand the management system
Organizations preparing to implement ISO 13485:2016 standard requirements
New staff members joining an organization with ISO 13485:2016 standard requirements and requiring in-depth knowledge


What will I learn?

  • ISO 13485:2016 scope and structure
  • ISO 13485:2016 requirements
  • How ISO 13485:2016 requirements are established and maintained in an organization

The medical device industry is a complex and difficult industry that only those with industry experience can understand and solve. Our team of professional consultants has the skills and talent to address these challenges in depth and create product-specific solutions.
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