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Medical Device School

Includes the NEW Medical Devices Regulation

12 - 14 November 2019

Radisson Blu Edwardian Grafton, London

The final text of the Medical Device Regulation has now been published - use this course for an up-to-date understanding!

Medical Device School provides an ideal opportunity to gain a comprehensive overview of medical devices in a relaxed learning atmosphere. Get to grips with the entire medical device lifecycle, through the research and development stages to latest updates in regulatory requirements and post-market considerations. The school will provide an in-depth focus on the changes within the global regulatory landscape, including discussions on Brexit and the new Medical Device Regulation. 

The three-day event is composed of a mixture of lecture style presentations and practical sessions where all can benefit from the speakers’ wealth of knowledge. Gain valuable information and share experiences with some of the most highly respected professionals in the field, normally only available when attending several different conferences! 

Our School includes 5 interactive learning sessions on: Classification, Risk Management, Biocompatibility, Vigilance and Human Factors Engineering.

 

Highlights

  • Gain valuable updates and insight into the new Medical Device Regulation (MDR)
  • Our School includes 5 interactive learning sessions on: Classification, Risk Management,
  • Biocompatibility, Vigilance and Reimbursement
    With 10+ speakers you will share experiences with some of the most highly respected professionals in the field

 

Key Benefits

  • Understand and explore the latest changes in legislation surrounding the new Medical Device Regulation (MDR)
  • Learn the fundamentals of device regulations such as classification and conformity assessment
  • Discover how to conduct a biological evaluation
  • Examine the importance of having a robust risk management plan
  • Gain an insight into clinical investigations for devices
  • Understand the need of having a quality management system in place
  • Discover optimal reimbursement strategies to get your device paid by healthcare providers such as the NHS
  • Gain an insight into post market surveillance and vigilance to ensure your devices continue to be safe on the market

The school is designed for all those who want to improve and broaden their knowledge of the medical devices industry, whether you are an existing employee, graduate, new to an area/department or somebody who would benefit for future career development.

Get more information on the topics that are important to you, for free...

Book your place at the Medical Device School in April 2019 and you will receive a free place on an MDTI online academy of your choosing.

Developed by our expert faculty and requiring an average of just 2 hours per week of your time, MDTI online academies are ideal for busy professionals.

Take the place yourself or offer it to a colleague, your options are:
1) Understanding ISO 13485:2016, starting 4 February 2019
2) Fundamentals of Risk Management, starting 4 March 2019
3) Fundamentals of the European IVD Regulation, starting 4 March 2019
4) Medical Device Regulations in Russia, starting 4 March 2019
5) Medical Device Regulations in the MENA region, starting 1 April 2019

To claim your free online academy simply quote your unique VIP code if you have one when you register, or speak to our training consultant to find out more at: Nabihah.Durrani@KNect365.com.

 

Eye opener in regards to some of the challenges connected to medical devices in the 21st century.

Professor,

NTNU: Norwegian University of Science and Technology

The course was very applicable. Presenters were very knowledgeable and presented their sections professionally and met the objectives. I would recommend it!

Regulatory Compliance, GSK


ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls

Free Recorded Webinar: Clinical evaluations, incorporating biological evaluation and PMCF with Sam Martin

In c.30 minutes, gain an overview of clinical evaluation and how it interacts with biological evaluations and post marketing clinical follow-up. Webinar highlights include:

  • Introduction to clinical evaluations
  • Discover how to incorporate biological evaluations into the clinical evaluation
  • Examine best practices to combine PMCF data into the clinical evaluation

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