Dear Medical Device Professionals

We are pleased to informed that we are conducting the Medical Device Clinical Evaluation Workshop. Please see below for details of workshop.

Trainers : Jeffrey Chern and Tan Hwee Ee.

Date : Postponed (To be advised) (2 day workshop).

Time : 9am to 5pm.

Venue : DH RegSys, Singapore.

Fees : SGD2800 per pax. Fees does not include GST.

Scope of workshop

  • The process of clinical evaluation based on GHTF and MEDDEV guidances.
  • How to target equivalent device based on intended use and marketing history ?
  • Literature review on scientific and medical publications, regulatory information and post market information.
  • Demonstration of evidence of preclinical safety and performance evaluation , including risk control/mitigation information.
  • Risk-benefit analysis for risk control/mitigation measures.
  • Appraisal of clinical evidence and justification for clinical utility

Note : The proposed dates are subject to change and we will inform all participants 1 month ahead.
Please contact Andrew Ho (email aho@dhregsys.com) to register your interests to attend this workshop.

Click here to register.
OUR PARTNER
  • MD-CLINICALS Europe

    Route de Denges 28C
    1027 Lonay
    Switzerland

    Phone: +41 21 349 96 36
    Mobile: +65 98656730
    Fax: +41 21 349 96 37
    Site: www.md-clinicals.com
Call us at 6659 0979
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