Professional Training

Medical Device Regulatory Project Management

PTI, In London
2 days
2 days
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Course description

How can regulatory affairs professionals benefit from project management in the medical devices industry?

2020 marks an important date for the Medical Devices industry, as the European Union's Medical Device Regulation (MDR) will take effect. Two years after, the In Vitro Diagnostic Medical Devices (IVDD) will follow. These regulations are set to constitute major changes for the industry, and these changes bring a high degree of uncertainty with them. Recognized as a key principle for success, effective project management could be applied to regulatory challenges for medical devices and help navigate through this trying time.

Over two days, delegates will gain a solid understanding of the core ingredients needed for a successful project management, with insight into future challenges and how to tackle them. Delegates will be able to cement this knowledge through case studies and practical exercises.

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Suitability - Who should attend?

This course is ideal for professionals with a minimum of 3 - 5 years' experience, or those who are mid to senior level regulatory affairs professionals in the medical devices industry. 

Additionally, both experienced project managers and project managers looking to apply their knowledge in the medical device industry would benefit, as this course focuses on managerial and leadership development - alongside new Medical Device Regulation (MDR).

Training Course Content

  • Introduction to Project Management
  • Applying Regulatory Requirements to Project Management
  • Managing Regulatory Changes and Communicating with Authorities
  • A Closer Look at Clinical Evaluation in a Project
  • Applying Risk Management in a Project
  • Managing Project Cycles
  • Cement this knowledge through practical group exercises and case studies

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


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