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Understanding Labelling and UDI for Medical Devices and IVDs (LIVE online)

PTI
Course summary
2 weeks
English
Online courses
Professional Training

Course description

Understanding Labelling and UDI for Medical Devices and IVDs (LIVE online)

As the Medical Devices and IVD industries transition to the new Regulations, organisations must implement new processes across a wide spectrum of regulatory areas to remain compliant. Labelling is one of these areas which has undergone a change in requirements and now includes Unique Device Identification (UDI) and expanded content requirements.

On this course you will explore the new requirements, cross examining them with the requirements of the Directives. You will deep dive into the UDI requirements, fully understanding what is needed on the label and how it links up with the new EUDAMED database. Crucially, you will develop strategies to transition to the new labelling requirements, considering supply chain issues and Notified Body concerns. You will also explore how labelling is connected important areas/departments like PMS and design development and how these areas can influence the label.

Suitability - Who should attend?

This 2-day course is aimed at regulatory professionals who are involved in device labelling and require a comprehensive understanding of the requirements under the MDR to ensure compliance. These include:

  • Regulatory affairs
  • Quality
  • Project managers
  • Product launch team
  • Design and development team

Training Course Content

  • Examine the labelling requirements under the new MDR / IVDR
  • Fully understand the UDI requirements and explore strategies for implementation
  • Assess labelling for specific cases such as single use, sterilisation and storage temperatures
  • Navigate the new usability requirements and IFU
  • Compare the new labelling requirements with MDD / IVDD

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

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http://www.pti-global.co.uk


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