Understand the additional requirements of the Medical Device Regulation (MDR), including the current directives MDD 93/42/EE and ISO 13485:2016, terminology and certification requirements.
The new European MDR rules will apply after a transition period of three years. To help medical device manufacturers understand the additional requirements of the regulation, we have developed the MDR Implementation Training Course (EU) 2017/745.
Course Objectives
This course will help you to understand:
- The MDR’s additional requirements
- The current directives – MDD 93/42/EE and ISO 13485:2016
- Terminology and certification requirements
Target Audience
This training course is for:
- Regulatory personnel
- Managers
- CEOs
- CFOs
- Medical device industry employees
- Medical device users
- Anyone who wants to learn about the new regulation
Course content
The course covers the following topics:
- Scope, definitions and classifications
- Conformity assessment procedures
- QMS requirements
- General safety and performance requirements
- Technical documentation requirements
- Clinical evidence
- Post-market surveillance and vigilance
- Risk management requirements
- Identification and traceability
- Supply chain requirements
- Transition and next steps
- Business impact, timeline and portfolio planning
Completion criteria
Learners are required to demonstrate acceptable performance to complete the course successfully. Upon successful completion, learners will be issued with a certificate of attendance.
Trusted MDR training from a world-leading provider of corporate education
As the world leader in professional training, we offer you unrivalled experience and a global network of qualified professionals with extensive expertise in the latest practices. SGS Academy is present in more than 45 countries and trains more than 200,000 professionals worldwide.
To find out more about our MDR (EU) 2017/745 implementation training course, or to book your place, contact us today.