ISO 14971 – Risk Management System for Medical Device
- 1° EDITION: 15 November 2024
- 2° EDITION: 14 April 2025
- Online
-
Italian
- 1° EDITION: 15 November 2024
- 2° EDITION: 14 April 2025
- Online
-
-
Italiano
-
Training overview
The training course ” ISO 14971 – Risk Management System for Medical Device” will discuss the standard ISO 14971, which specifies terminology, principles and a process for risk management related to medical devices and in vitro diagnostic medical devices. Effective risk management helps organizations identify hazards associated with medical devices, estimate and evaluate associated risks, and take advantage of opportunities. Standard ISO 14971:2019 aims to ensure essential safety requirements at all stages of the medical device life cycle, from design, to manufacturing information and finally to post-production.
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*!
Choose among these titles:
- Affari Regolatori Dispositivi Medici
- ISO 14971 – Gestione del Rischio
- Drug Device Combination Products in EU and US – English training
- La Valutazione Clinica dei Dispositivi Medici
- ISO 13485 – Il Sistema di Gestione della Qualità
(*) 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
- To provide the operational tools for risk management applied to medical devices extended to all product realization processes at all stages of the life cycle
- Identify, in the product realization process, the critical steps for the safety of a medical device
- Insight into the risk management process in the medical device environment
09:00 – 13:00 COURSE SESSION
- Hints at basic definitions/terminology/concepts
- Analysis of the requirements of ISO 14971:2019
- Risk Management during the life cycle phases of a medical device
- Logical steps of the Risk Management process: analysis, assessment, risk control, and evaluation of residual risk acceptability
- Post-production
Medical Device Designers, Regulatory Affairs Specialists, Quality System Manager and Product Certification and Consultants.
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 info@pharmaeducationcenter.it 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 info@pharmaeducationcenter.it. 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.
Speakers
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
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.
Register now
580€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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