Join us for an intensive 2-day course on the European Medical Device Regulation 2017/745 and acquire the solid foundation you and your team need to tackle this new challenge. Through practical cases, working session and discussion with a seasoned lead auditor, prepare for the new Regulation 2017/745.
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Apply the Promo Code : JULY4
Understand the Medical Device Regulations approach in Europe
Know the expectations with the use of the Essential requirements
Understand how to read the Classification Criteria and Implementation rules
Learn how to identify:
the applicable conformity assessment routes for your device(s),
the impacts on the Technical Documentation
The expectations and requirements with regard to Clinical Data and Clinical Evaluation
Post market surveillance and reporting requirements in the MD
WHO SHOULD ATTEND
Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D, Development, Manufacturing and Marketing Managers,
Internal and external Auditors
Practical working sessions
Lunch meeting with the trainer ( Lead Auditor and Technical File Assessor for high risk devices)