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RAQAexpert

Predictable and sustainable market access

We help you with securing access to the markets you choose to be on and make sure you stay there!

Todays regulatory environment requires manufacturer, distributors and importers to really plan the market access for new devices but also ensuring that existing devices are kept on the market! We are like the name indicates experts in Regulatory, Quality systems and Compliance!

We can help you with everything you need to secure market access!

Medical devices

Our core competence in medical devices covers most markets like the EU MDR, FDA QSR China and Japan compliance, but in todays world access to other markets might be as important. We have extensive experience in most types of products ranging from traditional medical devices like X-rays, Radiotherapy, Surgical equipment´s etc but also “new” type of medical device like wearables, robotic and software. Regulatory compliance and quality system is our core competence

IVD products.

The biggest ongoing change in regulatory requirements are happening for In vitro diagnostic devices (IVD). The requirements is strengthen up in most countries. We can help you to get to the market both with instruments but also for assays. Regulatory compliance and quality system is our core competence.

“We secure predicatable and sustainable market access for most markets in the world!”
We can help with parts or the complete process.

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“We had never passed the FDA audit without your help”
Thomas M, Company in radiation therapy
“With your advice we avoided all costly mistakes and got very quick to the market”
Dan B, Surgical tool manufacturer

Latest News

Read about the latest news about what happening in the world of Regulatory Affairs, Quality assurance and compliance but also about our company and what we are up to!

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