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!
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
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.
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!
Site now live
We have now open In order to serve our customers better we have created a second site to focus
Upphandlingskonferansen April 2021
One of our founder will speak at the ”Upphandlings konferensen 2021” together with the Swedish competent Authority
Regulatory conference in March 2021
Currently the plan is that one of the co founder of RAQAexpert to speak at the biggest