Strategy - Project Management - Implementation

The last years have shown a global trend to enforce Medical Device companies to enhance traceability by implementing UDI and similar requirements across the globe. Latest the EU Commission has followed FDA and released the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 affecting all device manufactures with business in the EU. How will this affect organizations? Will the impact be in a negative or positive way?

 

At Rosholt Consulting, we believe in the latter. We are dedicated to turn complexity into operational solutions and create competitive long-lasting company advantages by balancing regulatory requirements, with master data potential and operational capabilities thus creating a long lasting regulatory strategy and a plan that will implement it. Being it MDR, UDI or related Projects they are true cross functional and requires dedicated resources to accomplish in due time with the expected strategic benefits. We acknowledge the fact that finding the resources with the right knowledge and availability can be troublesome. This is our vocation, this is the world where we strive to share our knowledge to implement all new requirements and at the same time achieve the benefits derived from these projects.

 

 

That is why we are here, please find out what we have to offer under Solutions and Services.

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