Medical Devices Israel training courses

Medical Devices Israel training courses

Discover how to bring a successful medical device to market within this highly regulated sector.

Discover how to bring a successful medical device to market within this highly regulated sector.

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Medical devices training courses

Medical device trainingWe understand the challenges of meeting regulatory requirements and maintaining quality management systems. We understand because it's what we do, every day of every week; for you, for your customers, and for your bottom line.

We have dynamic course owners around the world, allowing delivery of training in many local languages. Our course owners are subject matter experts and use practical examples from their experiences to bring each lesson to life.


ISO 13485:2016 training courses

CE marking training courses

Requirements of the In Vitro Diagnostic Regulation >

Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives.

€1100

Requirements

Implementation of Medical Device Regulation for CE Marking >

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

€2500

Implementation

Implementation of the In Vitro Diagnostic Device Regulation for CE Marking >

Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.

€2500

Implementation

Specialist training courses

ISO 14971:2019 Requirements >

This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices.  It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745.

€1100

Requirements

Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods >

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.

€1100

Introduction

Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs) >

This intensive one day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

€1100

Performance evaluation and clinical evidence

Global market access training courses