SHARING OUR VISION

To ensure that people understand the regulations and quality systems role in creating a successful business.

To fully understand the effects a new regulation has on a business it is important to be trained and hear what others have done. In our trainings we limit the class to max 20 people to ensure that you have the chance to hear and be heard and talk about you particular problems. In order to give our customers a quick planning.

PRRC

Do you need to now what Person Responsible for Regulatory Compliance (PRRC) requirements means to you!

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Technical dokumentation

Do you need to know what the requirements are on the technical documentation required by IVDR and MDR this is the training for you!

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General MDR

Do you need to understand the new regulation, MDR in EU for medical devices this course is for you!

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General IVDR

Do you need to understand the new regulation, MDR in EU for medical devices this course is for you!

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FDA QSR requiremnts

Understand the QSR requirements and what they means to you in practice.

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Economic operator

We go through what IVDR and MDR means for Distributors, Importers and Authorized representatives.

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