Quality Management System in compliance with ISO 13485
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Establishment of a Quality Management System in compliance with ISO 13485

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Learn ISO 13485:2016 Quality Management Systems. Implement, maintain, and certify compliance. Two 4-hour sessions for medical device professionals.

ISO 13485:2016 is an internationally recognized standard that dictates the standards for quality management systems in the medical devices industry. This standard establishes the necessary requirements to implement an effective quality management system, ensuring that medical products and/or related services meet customer needs, as well as applicable regulatory requirements.

The “Establishment of a Quality Management System in compliance with ISO 13485” training course provides the tools and knowledge needed to design, implement, and maintain a quality management system in accordance with ISO 13485, ensuring the robustness of processes and regulatory compliance of medical products.

  • Introduction, terms, and structure.
  • Analysis of ISO 13485:2016 requirements.
  • Evaluation of the impact of ISO 13485:2016.
  • Definition and planning of a quality management system.
  • Implementation process of a quality management system.
  • ISO 13485:2016 certification.

Aimed at professionals in the medical device industry who want to implement a quality management system in accordance with ISO 13485:2016.

Adi Ickowicz, BSc, ME
Senior Principal at the MedTech Unit of Asphalion

With over twenty-five years in the MedTech industry, Adi’s extensive background includes leadership roles in regulatory affairs, clinical, and quality assurance departments across both well-established firms and start-ups. Additionally, he is a lecturer in various academic institutions.


Talyta Carteano
Medical Devides director

Over 10 years’ experience in the Medical Device Industry, as well as experience as R+D Project Manager focused on the development of Mechanical and Electronic Medical Devices.

Expertise in developing, controlling and auditing Quality Management Systems in accordance with ISO 13485 and in IVD self- testing.

Scientific assessment in development of innovative medical devices; due diligence of registration dossiers; writing of regulatory documentation (technical files, FDA clearance.); life cycle maintenance; project and team management.

Leading expert and lecturer in the new Medical Device (MD) and In Vitro Medical Device (IVD) Regulation.  Working as expert in the preparation of Regulatory Roadmaps and regulatory strategy for complex MD and IVD.

Regulatory Work Package Manager of H2020 projects.

The course is delivered in two 4- hour sessions (8 hours).

Price: 800€

Early Bird: 10% discount up to 30 days before training date.


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