Internal Auditors ISO 13485
Dates TBD

Internal Auditors ISO 13485

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Unlock ISO 13485:2016 auditing expertise. Master compliance, audit essentials, and boost your medical device quality management skills.

ISO 13485:2016 is a globally recognized standard that governs quality management systems in the medical devices sector. It provides an effective operational framework for organizations to meet relevant regulations and obligations.

The “Internal Auditors ISO 13485” training course provides participants with the skills and knowledge needed to carry out internal audits of medical device quality management systems according to ISO 13485:2016, ensuring compliance with regulations and continuous improvement.

This course is designed to provide the necessary knowledge for conducting internal audits of medical device quality management systems according to ISO 13485:2016. The following points will be analysed during the training:

  • The importance of internal audits and auditor responsibilities.
  • Requirements of ISO 13485:2016.
  • Stages of the audit process
  • Classification of Non-Conformities.
  • Audits planning and review.

Aimed at professionals in the medical device industry who want to conduct effective internal audits.

Basic knowledge of ISO 13485:2016 is recommended.

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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