MedTech SPIN: Medical Device Software

MedTech SPIN: Medical Device Software
The MedTech SPIN sub-committee, Software as a Medical Device, welcomes you to this presentation - Medical Device Software: Guidance on How to Perform a Clinical Evaluation.






Date: Tuesday 31 October 2023
Time: 13:30-14:30 GMT / 14:30-15:30 CET


The clinical evaluation of medical device software (MDSW) is a challenging task for App developers and manufacturers of MDSW. This webinar aims to provide insight into the clinical evidence needed for MDSW to fulfil the requirements set out in Regulation (EU) 2017/745 – Medical Device Regulation (MDR). The presenter will discuss how to structure a clinical evaluation, with an emphasis on how different types of clinical evidence feed into a clinical evaluation (i.e., valid clinical association, technical performance, and clinic performance). The presenter will use real-world examples of MDSW and will share his experiences from interactions with Notified Bodies. The practical information shared during the presentation will provide guidance to App developers and MDSW manufacturers on what clinical evidence to gather and how to structure a clinical evaluation. 


Our guest speaker:

Tjerk Zult PhD, Senior Medical Writer, Avania,  is a Human Movement Scientist with a strong track record in delivering against programs of high-impact clinical research. He has completed a PhD in Orthopaedics, Musculoskeletal Sciences, and Neurorehabilitation followed by 2.5 years of postdoctoral research training in Clinical Biomechanics and Vision Science. He has successfully coordinated research programs in collaboration with an international and multidisciplinary team, which have resulted in 10+ peer-reviewed publications in high-impact exercise science and medical journals. Tjerk is currently a Senior Medical Writer at AVANIA where he is involved in all clinical phases of medical device and IVD development, from regulatory consulting to study design, study report writing, and clinical evaluations/performance evaluations for the MedTech industry.    
 

Pricing
  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

 

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When
31/10/2023 13:30 - 14:30
Where
ONLINE
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