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Medical Device School

Includes the NEW Medical Devices Regulation

13 -15 November 2018, London

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!

The Medical Device School is an ideal opportunity for delegates to get to grips with the entire medical device product life-cycle, covering everything from research and development to gaining regulatory approval and getting your product to market. It is also an opportunity to discover how the new Medical Devices Regulation will impact you in your job role.

Gain up to date 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.

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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