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2021 Dates TBC, Radisson Blu Edwardian Grafton Hotel

2-day course

Develop improved tactics to ensure the effective life-cycle management of your medical device product

Course Overview

Designed for professionals with a working knowledge of regulatory affairs, this advanced course will provide a road map to support your transition from the current regulatory system based on Directives to the new requirements established by the Regulation. The course will include comprehensive sessions on technical documentation, the vigilance system, the regulatory hierarchy in the EU, labelling, clinical evaluations and investigations, EUDAMED, post-market surveillance and post-market clinical follow-up studies.

On completion of this 2-day course, you will have a more strategic grasp of the new Medical Device Regulation (MDR) and best practice to help transition from the Directive. You will explore key regulatory changes to the regulation from conformity assessment and clinical investigations to the new vigilance system and post-market surveillance.

As a Senior Medical Device professional, this course will provide you with a platform to discuss and share your challenges and concerns in a learning environment. Together you will discuss solutions that you can take away and apply in your roles. Dependent on delegate wishes, some time may be designated to discuss the implications of Brexit and future challenges for the industry.

What will you learn?


Introduction into the Medical Device Regulation
Introduction into the Medical Device Regulation

Understand the reason behind the new Medical Device Regulation

Key Stakeholders
Key Stakeholders

Explore the changes to roles and responsibilities of key stakeholders including competent authorities, notified bodies and economic operators

Classification Rules and Processes
Classification Rules and Processes

Investigate classification rules and processes, including software products


General Safety and Performance Requirements
General Safety and Performance Requirements

Analyse the General Safety and Performance Requirements and technical documentation requirements

Clinical Evaluations and Investigations
Clinical Evaluations and Investigations

Examine the guidance and requirements for clinical evaluations and investigations

Assessment Routes
Assessment Routes

Understand the different conformity assessment routes


Market Surveillance Tools
Market Surveillance Tools

Comprehend market surveillance tools such as EUDAMED and UDI

Post-market Surveillance and Vigilance Strategies
Post-market Surveillance and Vigilance Strategies

Implement effective post-market surveillance and vigilance strategies

Post-market Clinical Follow-up
Post-market Clinical Follow-up

Understand the different requirements and types of post-market clinical follow-up


Impact of Brexit
Impact of Brexit

Critically analyse the impact of Brexit and future trends/challenges in the industry

Who is this course for?

This course will provide experienced professionals with the regulatory knowledge to practically apply life-cycle management in an MDR environment, particularly to those who play a key role in transitioning their products to the MDR.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.

Examples of books and eBooks within medical devices include:

  • Medical Device Quality Assurance and Regulatory Compliance
  • Medical Instruments and Devices: Principles and Practices
  • Design Controls for the Medical Device Industry, Third Edition
  • Usability Testing of Medical Devices
  • And more