Qserve Global Services
Your global MedTech Partner for Regulatory Affairs, Quality Assurance, and Clinical Trials
Qserve’s mission
“Our mission is to support all medical device and in vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements.”
We strive to guide manufacturers in gaining and maintaining compliance for their safe and qualitative medical devices in the most streamlined way possible. Qserve’s global team combines their regulatory knowledge and experience in the medical device and in vitro diagnostics industry to assist manufacturers in marketing thousands of devices worldwide. The unique combination of regulatory knowledge and device experience is highly valued among our clients.
Why Qserve?
We care about health and are committed to guide new devices and new technologies through the labyrinth of regulations, worldwide. Qserve supports IVD and medical device manufacturers with our team that in total spans more than 900 years of healthcare experience, in industry, regulatory, clinical, and quality functions.
We have passion for complex regulatory issues. Technological complexity, globalization, scrutiny and healthcare regulations are evolving rapidly.
Qserve will go the extra mile to provide manufactures a pragmatic solutions approach that will last as well as costefficient options in our services. Together with manufacturers we determine the level of contribution from Qserve – we call this the ‘I do – We do – You do’ approach.
Interested to find out how Qserve can support you? Simply send your question to info@qservegroup.com and one of the colleagues listed will be contacting you and explore the best way to support you.
Market access
Before you can sell your products, you need to comply and meet the global regulations. Our international team, local offices and professional alliances support global market access.
Your global regulatory strategy
Depending on where you would like to go, there are several factors that affect the route you will choose. The best or most efficient route is based on your device, the different regulations, identified gaps, available budgets, and timelines. Do we have to start from scratch, or can we start abridged routes with similar executed processes? With our global expertise on regulatory compliance and local experts everywhere, together we can determine the best strategy and effective roadmap.
How to enter the global market?
We can help to determine which jurisdictions will be most suitable based on your current certification. From concept to global market access, we start creating your global strategy and write specific country overviews. What does it mean to you and how to enter the intended markets? We will review your technical documentation, provide support where necessary and ensure your documentation complies with the regulations.
