MDR - Economic Operator/ Supply Chain

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TRAINING

MDR - Economic Operator/ Supply Chain 

The deadline for compliance to the European Medical Device Regulation (EU-MDR) is May 2020.Manufacturers are strongly advised to start considering the impact on their activities as soon as possible.

Get to know the basics of the Regulations if you want to (continue to) market products on the European Market. You will learn about the structure and purpose of the EU-MDR including scope and classification changes, the Essential Principals, identify the revised conformity assessment routes and the increased importance of Risk Management, Clinical Data, Clinical Evaluation and Post Market Surveillance.

 

 

 

 

 

 

 Learning objectives: 

  • Understanding the roles and responsibilities and context of Economic operators within EU Medical Device Regulations.
  • Contents of contracts and quality agreements and required communication.
  • How to establish, monitor and maintain the mutual agreements of manufacturers with the other economic operators (including Authorized Representative and Importer)  and suppliers/ subcontractors.

Who should attend?

Professionals in QA and RA, Internal Auditors, supply chain management, purchasing, incoming inspection and legal.

Costs

We offer open enrolment, on-location, train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.

Costs: € 875.- p/p for a one-day training

How can we help you? Contact us