ISO 13485 – The Quality Management System for Medical Device

  • 2° EDITION: 18 June 2024
  • Online
  • Italian

Training overview

ISO 13485:2016 specifies requirements for a Quality Management System that can be used by an organization in the design, development, manufacture, installation, and service of a medical device, as well as in the design and delivery of related services that also covers areas such as logistics, distribution, testing, calibration and sterilization. ISO 13485:2016 is therefore aimed at organizations interested in the entire “life cycle” of medical devices. The main objective is to foster global harmonization of requirements for MD standards.

The training course “ISO 13485 – The Quality Management System for Medical Device” will examine the norm and highlight the most important points with the help of examples.

Are you interested in Medical Device training?

Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
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(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.

Key points of the training

  • Understand the requirements of a Quality System for medical devices
  • Share an overview of management systems for quality
  • Understand the requirements of ISO 13485:2016 including through comparison with ISO 13485:2003 and the differences from ISO 9001:2015
  • Understand how to conduct internal audits that comply with the standard by taking a risk-based approach
  • Provide insights for your own Quality System

09:00 – 13:00 COURSE SESSION

      • Requirements for a Quality Management System Applied to Medical Devices
      • Overview of the Standards for Quality Management Systems
      • Main aspects of ISO 13485:2016: documentation, resources management, monitoring and improvement
      • Risk-based thinking and auditing with a process-oriented approach
      • Risk management
      • MDR 2017/745: insights and obligations for economic operators

Managers of the Quality Management System and Regulatory Affairs, Managers relating to the medical devices sector, Managers of other company areas.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Rosamaria Castagnozzi

Rosamaria Castagnozzi

Drug Safety - Medical Device Strategist | Biochem Srl

Laureata in Scienze Biologiche presso l’Università degli Studi di Napoli “Federico II”, con specializzazione nel Dipartimento di Biologia, ha successivamente completato un Master di II Livello in Scienza e Tecnologia Cosmetiche presso la stessa università nel 2023.

Ha svolto attività di ricerca presso il “Biogem Istituto di Ricerche Genetiche”, focalizzandosi sui Medical Devices e farmaci per il trattamento del cancro della mucosa gastrica, tra il 2019 e il 2020. Successivamente, ha svolto un tirocinio formativo presso Biochem Srl nel 2021-2022, concentrandosi sugli affari regolatori per i dispositivi medici.

Attualmente, lavora come Drug Safety – Medical Device Strategist presso Biochem S.r.l. a Casoria (NA). Le sue responsabilità principali includono la consulenza regolatoria per il settore dei dispositivi medici, la redazione e l’aggiornamento della documentazione tecnica in accordo al Regolamento UE 2017/745 (MDR), la valutazione clinica, la vigilanza e la sorveglianza post-marketing, nonché la redazione di piani e report PMS, PMCF, PSUR. Ha acquisito il ruolo di Persona Responsabile della Normativa e ha contribuito alla gestione della qualità in accordo alla normativa ISO13485.

Ermando Maisto

Ermando Maisto

Senior Consultant for Medical Devices | Biochem Srl

Laureato in Chimica presso l’Università di Napoli “Federico II”, è iscritto all’Ordine dei Chimici della Campania nel settore farmaceutico ed è Consulente per il Tribunale di Napoli settore farmaceutico.

Attualmente è Consulente Senior per i dispositivi medici per BIOCHEM SRL.
Le sue responsabilità principali includono la consulenza regolatoria per il settore dei dispositivi medici, la redazione e l’aggiornamento dei fascicoli tecnici dei Dispositivi Medici in accordo al Regolamento UE 2017/745 (MDR), la redazione della Valutazione Clinica e PMCF dei Dispositivi Medici, e la sorveglianza post-marketing dei Dispositivi Medici.

In precedenza, ha ricoperto il ruolo di Responsabile Affari Regolatori per i dispositivi Medici presso Astra Zeneca Group & Martina S.P.A. Ha inoltre lavorato come Responsabile Junior Affari Regolatori per dispositivi medici e farmaci presso Amersham Pharmacia Upjon.
La sua esperienza comprende consulenza e informazioni sui dispositivi medici, oltre alla gestione di affari regolatori nel settore farmaceutico.

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Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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