Summary
This three-day course will give you a thorough overview of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation. You will leave with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, study design, and practical considerations for how they are performed and documented.
Learning Objectives
- Gain an update on the regulatory requirements
- Understand different study types
- Determine whether or not a clinical investigation is required
- Understand sufficient quality & level of evidence requirements
- Determine technical, biological, and clinical evidence for a development plan
- Understand ‘state of the art’ in medicine
- Assess the usability of medical devices registries
Key Topics
- Regulatory requirements & pathways (EU, US and UK)
- Study types & design
- Clinical evidence – clinical development plan, clinical benefits
- Clinical investigations – process, risk, parameters & design
- Post-market surveillance
- Medical device registries
Who should attend?
This course is suitable for all those involved in:
- Clinical Studies/Trials/Affairs Professionals
- Regulatory Affairs Professionals
- Quality Professionals
- R&D Professionals
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Michael worked for Innovate UK for four years as a Health Innovation Lead and was responsible for the management of a UK government grant funding programme called the Biomedical Catalyst that provided £30M per annum to supports UK SMEs developing innovative health & life science products. Before joining Innovate UK, Michael was a Group Manager at Medicines & Healthcare Products Regulatory Agency (MHRA) where he led a team that was responsible for safety & surveillance of all medical devices in UK.
Clinical Investigations for Medical Devices
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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