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Turning regulatory complexity into digitized, compliant and operational solutions that create competitive long-lasting company advantages for the future

Analyse - Strategy Implementation

 

The nature of development in the life science industry as well as a solid stream of new regulations on a global scale push Medical Device companies to keep improving and developing processes that are digitized, scaleable and ready for global implementation.

 

Example: The new EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746  released by the EU Commission affecting all device manufactures and economic operators with business in the EU in wide variety of areas. One area is the Unique Device Identification (UDI) requirements added to improve traceability, UDI will be affecting RA, QA, R&D, IT, Master Data, Operations and Supply Chain functions

 

How does the constant changes affect your organization? Will the impact be negative or positive?

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Rosholt Consulting, we believe that changes are positive

Why is that? Simply because a thorough Analysis, well argued Strategy and a structured Implementation is a proven way to improve your processes leaving you a better place than you started. 

How? The Analysis phase is used to visualize the areas of attention and cast light on the gaps and improvement possibilities in you company. This knowledge is combined with the strategy in your company creating a clear path for your projects with measurable metrics. The implementation phase can be supported using our long experience driving project mangement in regulated life science businesses. 

In short: We are dedicated to turn complexity into operational solutions and create competitive long-lasting company advantages by balancing regulatory requirements, with digital/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, implement all new requirements and achieve the benefits derived from these strategic projects. 

Please find out what we have to offer under Solutions and Services.

 

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