Language: English.

Venue: Oslo Science Park, Gaustadalléen 21, 0349 Oslo.

Are you developing medical devices or are you transitioning from directive to regulative? Then you should consider attending this course!

Norway Health Tech is invites you to a course on the requirements in MDR/IVDR. This full day course will thoroughly go through the requirements in these two regulatives leveraging the expertice of Yallow Life Science.

The course lasts for one full day – from 09:00 until 16:00 and contains lectures and group work

Who should attend?

The training course is intended for, but not limited to

• Regulatory affairs personnel
• Persons responsible for regulatory compliance
• Quality assurance professionals
• Top management or management in R&D, design, manufacturing, supply chain, customer service and sales
• Staff working for organizations that partner with medical device manufacturers, such as subcontractor, supplier, OEM, authorized representative, importer, distributor
• Anybody who wants to learn about the new European regulations for medical devices

What will you learn?

By the end of the training course you will be able to:

• Understand the content and structure of the European Regulations for medical devices
• Communicate the key requirements introduced by the MDR and/or IVDR to your organization
• Better identify what affects your product and your company and to what extent
• Define the vocabulary used within MDR and IVDR
• Recognize stakeholders affected by the Regulations
• Describe key steps of a conformity assessment
• Explain the main impacts on the quality management system relating to the Regulations
• Recognize requirements for post-market surveillance

What’s included?

• Training course materials
• Lunch and refreshments
• Certificate of attendance

Price:

Norway Health Tech members: kr 5 900,-

Others: kr 9 900,-