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Medical Device Software and Apps - Online Academy

3 week online course beginning on Monday 2nd July 2018

Online Academy

Navigating the regulations that surround software and applications used in a healthcare environment is challenging with little information available to developers. It is important to remain up to date with regulatory changes and know which requirements are relevant to your products. Over 3 modules you will gain a solid grounding in the regulatory requirements that surround mobile phone apps and standalone software and will be better placed to know the optimal route to market for your product.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 

 

Over 3 weeks students will learn through:

  • 3 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 3 weeks the course is running
  • Additional content such as materials and white papers available to download

Peter Brady

Peter is a med-tech specialist with a deep understanding of medical device development, the healthcare industry and international regulation and standards. He has key skills in all aspects of complex device development, safety risk management and software security with experience ranging from low cost high-volume devices to the most sophisticated medical technologies in existence.

Peter also has extensive experience in healthcare sectors including oncology, proton therapy, medical imaging, implantable devices, renal therapy, diabetes management, vascular therapy, minimally invasive surgical devices, pressure area care, point-of-care diagnostics and drug delivery.

Peter is an approved EU Notified Body “Subject Matter Expert” for Medical Device Software.

  • Discuss the definitions of various software and apps including: standalone software, mobile applications, IVDs, active implantable
  • Analyse the regulatory requirements such as classification and PMS
  • Examine the criteria to determine whether your software is a device or not
  • Assess the various routes to market for a software/app when it is a device: CE marking, Notified Body, conformity assessment.
  • Assess the routes to market and alternative regulations when the software/app isn’t a device

This course is aimed at professionals who are seeking to gain clarity on the requirements for software and apps used in healthcare gain in:

  • Regulatory Affairs
  • Medical writing
  • Quality
  • Scientists

What happens during an Online Academy course?

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This online academy course can be accessed from 2nd July 2018. 1 module will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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