Ensuring market access for sustainable and safe medical devices

Most MedTech and welfare tech companies face challenges when implementing new technological and sustainable solutions, when compliance with standards, regulations and consumer safety remain the highest priorities.

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Time-to-market is a challenge for MedTech and welfare tech products

Time-to-market is crucial for the competitiveness of companies producing devices, products, or equipment within MedTech and welfare. Short R&D cycles, rapidly evolving technology, growing risk awareness and increased user involvement all contribute to the need for more innovative use of technology to ensure fast launches of products. And when it comes to connected devices, e.g., remote monitoring or app-based solutions, cyber security is key.

But, in a heavily regulated industry such as MedTech and welfare tech, it can be challenging to implement new technological and sustainable solutions when compliance with standards, regulations and consumer safety remain the highest priorities.

 
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An easy and safe way to customers and end users

That is why we strive to make innovation, development, test and launch of new medical devices and equipment easy and safe. To do this, we apply our impartiality and technological expertise, combined with regulatory knowledge and active participation in standardisation committees, and we ensure access to a wide range of testing facilities.

 

Shorter time-to-market without compromising quality

We ensure market access through:

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Product approval of medical devices

Ensure your medical device’s compliance with regulatory requirements, such as MDR, already in the RnD phase.
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Chemical test of equipment, incl. PPE

Testing and approval for importers, manufacturers and distributors that documents your product’s compliance with existing market standards.
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Life cycle assessment (LCA) of products

Life Cycle Assessment makes it possible for you to document and explain how your product or service impacts the environment.
Jens Roedsted

For more information, contact

Jens Roedsted

Chief Operating Officer

T: +45 22 69 74 36