Premier Research offers the most comprehensive medical device clinical and regulatory training courses available today. All courses are conducted either on-site or at our facilities in Switzerland by highly experienced medical device professionals and can be tailored to meet any specific needs. For more information on booking training courses, please contact us. Basic Monitoring Course for Medical Device Clinical Investigations
This GCP certification program focuses on monitoring of medical device investigations taking into account the appropriate regulatory requirements as well as device specific approaches to greatly increase monitor efficiency and success.
Medical Device Trials: How to Comply with the Regulations
In-depth review of EU regulations, including an update of European national requirements, Ethics Committee, overview of the ISO 14155, data protection requirements and vigilance reporting for clinical investigations are provided in this course.
Critical Literature Review
Course duration: ½ day
Participants will learn to implement critical literature review in their clinical strategy and use the appropriate processes as successful tools to CE mark and how to distinguish when to use the critical literature review route or in combination with a prospective clinical investigation.
Post Market Surveillance Process for Medical Devices in the EU
Course duration: ½ day
Review of the regulatory requirements in Europe for vigilance and post market surveillance including a practical approach on how to setup a system to comply with the regulations for your specific product are provided in this session.
Vigilance Requirements in the EU
Course duration: ½ day
Review of the regulatory requirements in Europe for post market surveillance and vigilance including practical approach of how to setup a system to comply with the regulations for your specific product are provided in this session.
Case Report Form Designs
Course duration: ½ day
This course reviews the requirements of overall CRF design, practical examples of do's and don'ts, and reviews the data flow and how to ensure full traceability.
Project Management for Medical Device Clinical Investigations in Europe
Course duration: 1½ days
This course provides practical and innovative information and tools which will allow you to quickly set-up and manage your clinical investigation, tracking and budgeting concerns with the highest quality and quickest timelines.
Customized courses are also available. For more information on the above or customized courses, please contact us.
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