Fundamentals for Clinical Affairs
Dates TBD

Fundamentals for Clinical Affairs

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Explore Fundamental Clinical Affairs for Medical Devices: Ensure Compliance and Patient Safety with Expert Guidance.

Clinical evidence is key to demonstrating the safety, performance, and benefit of medical devices. To address this matter with confidence, it is important to be familiar with and understand the requirements derived from European laws and guidelines for the clinical evaluation of medical devices, covering the entire product lifecycle. This includes the general procedure of a clinical evaluation and the required content of the documents to be prepared, as well as clinical evaluation in the post-market surveillance phase, including clinical follow-up.

The “Fundamentals for Clinical Affairs” course introduces participants to critical aspects of clinical trials and post-market studies of medical devices, providing information on design, execution, and regulatory requirements, ensuring both compliance and patient safety.

  • Basic requirements for clinical evaluation according to MDR and relevant guidelines (MEDDEV and MDCG).
  • Stages of the clinical evaluation process and documentation requirements.
  • Relevance and typology of clinical data for the approval and marketing of medical devices.
  • Clinical strategy for determining the path of clinical evaluation.
  • Need for clinical investigations for conformity assessment procedures.
  • Demonstration of equivalence of other devices.
  • Identification, evaluation, and analysis of clinical data.
  • Content of the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER).
  • Updating risk analysis in the evaluation of clinical data for medical devices and risk-benefit assessment.
  • Requirements for post-market clinical follow-up.

Aimed at professionals in the medical device industry with prior knowledge of clinical affairs and/or involvement in the clinical evaluation process of medical devices.

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 three 4-hour sessions (12 hours).

Price: 1.200€

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

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