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Fundamentals of EU Regulations for Medical DevicesPTI
Are you ready for the new Medical Device Regulations (MDR)?
In May 2017, the EU issued the new MDR to address weaknesses in the current law relating to medical device safety. As we are quickly approaching 2020, time is running out for the industry to begin facilitating the necessary changes relating to device classification, clinical evidence and safety reporting to remain compliant. This 9-module course will bring you up-to-speed with the fundamentals of the new MDR and the changes you need to understand to avoid costly delays and ensure quick market access for your medical device. Whether you are new to the medical device industry, or simply need an overview of the changes, then this course will provide you with all you need to know regarding the EU regulatory landscape.
Suitability - Who should attend?
This course is suitable for professionals who work in the medical device regulatory industry who need to understand the changes in the EU law. Particular areas may include:
- Regulatory Affairs
- Medical Device Development
- Clinical Investigations
- Chief Operating Officer – Doctors & Nurses etc.
- Adverse Events Reporting
- Research & Development
Training Course Content
- Grasp the changes that the medical device industry needs to facilitate to remain compliant with the new regulations
- Understand how to submit your documentation to ensure your device is in line with the updated general safety and performance requirements
- Familiarise yourself with the stringent clinical evidence requirements and vigilance reporting
- Learn to classify your device under the new guidelines
- Understand the post-market and surveillance requirements
- Become familiar with the good practices for clinical investigations and evaluations reporting detailed in ISO 14155
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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