Quality management systems for enterprises manufacturing medical products – ISO 13485.

Quality management systems for enterprises manufacturing medical products – ISO 13485.
It is necessary for all enterprises supplying medical equipment.

Development and implementation of quality management system
ISO 13485:2016
for enterprises manufacturing medical products. conducting an internal audit according to ISO 19011:2018.

This training is aimed at obtaining knowledge and the formation of practical skills in the construction and analysis of the functioning of the quality management system in the production of medical devices. The course is designed in accordance with the requirements of the international standard ISO 13485: 2016 to facilitate the continuous improvement and functioning of quality management systems. Our specialists in an accessible form and working examples will explain the need for each document and methods of implementation for each individual production.

Training Description


We will teach you practical methods of building a system and conducting internal audits.

  • 16 – hours of saturated communication with leading experts
  • Practical knowledge of what methodologies, procedures and documents should be in the enterprise
  • A description of the key problems of the enterprise and their solutions
  • Consultation with leading experts from various industries
  • Examination work
  • Obtaining certificates of an internal auditor

  • Introduction to standard
  • Documentation ISO 13485: 2016 structure, scope, management rules.
  • The main stages of development, implementation and preparation for QMS certification in accordance with the requirements of ISO 13485: 2016;
  • Building a process model of the QMS. Practical recommendations.
  • Risk management of medical devices.
  • Internal audit.
  • Final testing.

future trainings



The best teachers with practical experience

Convenient training venue

Availability of information

Electronic version of training materials

Answers to your questions during and after the training

Your future achievements


Thanks to the training, the development and implementation of ISO 13485: 2016 tens of companies received:

üReduced production costs

üGained practical knowledge of the standard

üImproved production infrastructure and upgraded

üPrepared for certification audit

üOptimized business processes

üIncreased staff qualifications

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What People Say

Training on the course “IFS Food v.6.1 Course for Internal Auditors” took place on November 8-9, 2028 in Lviv. Given the limited offering for training courses in this direction in Ukraine, it was very useful and informative to get information on the features of the construction of the IFS Food v.6.1 system and standard conceptual…


During the pre-certification audit conducted by TBG GmbH, our company employees fully understood the requirements of the GMP + B3 standard and refined their feed safety management system to the standard requirements. That really helped us get certified in the company GIC (Germany) and audit by GMP + !!!

Vilius Tamošauskas Company CEO

We are grateful to TBG specialists for the accessibility and understandability of the training conducted for our employees. Now we understand our areas for improvement and can prepare for enterprise certification!

Mironenko Alex Founder
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