Understanding the Medical Device Regulation (LIVE online)
In Europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the product’s safety & performance. To maintain patient safety the EU introduced the Medical Device Regulation (MDR) transforming and modernising the older Directives. Whether you are new to regulatory affairs, the MDR or are branching out from other areas of the wider medical device industry, this fundamental-level course will detail the EU regulatory requirements throughout the entire product life cycle.
Complemented with practical exercises and open discussions, you will gain a comprehensive overview of the essential European regulatory requirements to consider as you prepare for MDR implementation, including: the European regulatory landscape, device classification and conformity assessments, documentation and labelling requirements, post-market considerations, risk management and clinical evaluations.
Suitability - Who should attend?
- Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
- Those moving into Regulatory Affairs from other areas within a medical device company (Clinical Trial Evaluations, Marketing and others)
- Anyone wishing to update their knowledge on EU regulatory affairs
Outcome / Qualification etc.
- Learn about the NEW Medical Devices Regulation and how it will impact you
- Gain a thorough understanding of how the new Regulation will change future EU applications
- Learn how to classify medical devices
- Determine the correct information required for medical device labelling
- Understand the role of the Notified Body and Competent Authority
- Examine the risk management process for medical devices
- Discuss the regulatory challenges of software and methods to tackle these proble
Why choose PTI
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Quality of content:
85% had applied content during the course to their role
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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