Medical device clinical evaluation

  • 2° EDITION: 15 April 2024
  • Online
  • Italian

Training overview

With the applicability of Regulation (EU) 2017/745, there is a need to review the approach to the preparation of the clinical evaluation, which until now has been carried out mainly based on the guidance provided by the MEDDEV guidelines. The need to submit new documents (such as the Clinical Evaluation Plan and PMCF Plan) and the need to interface with PMS activities certainly make this task more complex than in the past. Although the topic is covered extensively in the new Regulations, to the requirements of which are added the indications of the various documents issued by the MDCG, there is a lack of a unified document that, by summarizing the requirements of the regulations, provides valuable guidance for the preparation of clinical evaluation. The training course “Medical device clinical evaluation” aims to offer a unified view of the various relevant documents, and also to propose a possible practical approach to the preparation of the clinical evaluation.

Are you interested in Medical Device trainings?

Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*.
You may choose from these trainings:

  • ISO 13485 – The Quality Management System for Medical Device
  • ISO 14971 – Risk Management System for Medical Device
  • Medical Device Regulatory Affairs
  • Medical device clinical evaluation
  • Advertising medical devices and dietary supplements
  • HIGHLIGHTED TRAINING – Combination Products in EU and US

(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.

Key points of the training

  • Better understand the requirements of the new regulations with reference to clinical evaluation
  • Clarify how clinical evaluation will fit into the context of other planned activities for medical devices
  • Verify the content of the various documents issued by the MDCG
  • Deepen some aspects related to the clinical evaluation of "legacy devices"
  • Better understand the various steps in the clinical evaluation process

14:00 – 17:00 COURSE SESSION

The Regulatory Context

Clinical evaluation according to Regulation (EU) 2017/745

  • The founding principles
  • The legal basis

The most relevant novelties

  • The clinical evaluation plan
  • The post-marketing clinical follow-up (PMCF)
  • The relationship with post-marketing surveillance (PMS) and risk assessment
  • Other relevant aspects

The clinical evaluation document: a practical approach

  • The different phases of the clinical evaluation

Regulatory Affairs, Quality Assurance, management personnel, research and development managers, production managers, process managers, managers/coordinators, complaint management and corrective and preventive actions, supervisory managers, marketing/sales managers.

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

Lorenzo Zanoni

Lorenzo Zanoni

Senior Medical Advisor: Scientific Service

He graduated in Medicine and Surgery in 1988 at the University of Pavia; he obtained the PhD in Microbiology in 1992 at the University of Brescia and the specialization in Clinical Biochemistry in 1998 at the University of Siena. For several years he worked in basic research, in the oncology sector, in Italy and abroad. He began to deal with “pharmaceutical medicine” in 1998, first as an employee of pharmaceutical companies and, since 2002, as a Medical Affairs advisor as a freelancer at CROs and pharmaceutical companies. He has participated as a speaker in numerous scientific seminars; since 2010 he has been collaborating with Pharma D&S.

Register now

Early Bird 10%
Within 2 months before the start of the training
350€
390€
Early Bird 5%
Within 1 month before the start of the training
370€
390€
Full price

390€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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