Dates TBD

Fundamentals for medical device Risk Management

English | 
Gain insights into ISO 14971:2019-compliant medical device risk management. Understand risk assessment, control, and safety compliance in the product lifecycle.

Risk management is an essential part of a quality management system. The reference standard for the risk management on the industry of medical devices is ISO 14971:2019 which specifies the terminology, the principles, and the process for the risk management of medical devices, including the software as a medical device and in vitro diagnosis medical devices. The use of the guidelines described in the standard helps the manufacturers of the medical devices identify the risks associated, estimate and evaluate associated risks, control these risks and follow up on the efficacy of the controls. Integrating the risk management on the early stages of the design process allows you to identify and consider situations potentially dangerous from the beginning.

The training course “Fundaments for medical device Risk Management” provides attendees with a comprehension of the processes of evaluation, mitigation and risks documentation adapted to the medical devices, emphasizing on the compliance of the rules and guarantee the safety of the patients during the lifecycle of the device.

  • Introduction to risk management during design, development, manufacturing and lifecycle of medical devices.
  • Concepts and objectives on risk management.
  • Risk management based on the norm ISO 14971:2019.
  • Relation of the norm ISO 14971:2019, ISO 13485:2016 and the European regulations for medical devices.
  • Analysis and risk identification, control measures, residual risks, and benefit-risk analysis.
  • Risk matrix.
  • Risk management and the relation with the post-commercialization follow up system, and the clinical evaluation and performance evaluation.

Aimed at professionals in the medical device industry. No prior knowledge is required.

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 a 4-hour session.

Price: 400€

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

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