Global Market Access
Our expertise in global market access will accelerate your time to market.
Where do you envision to obtain market approval?
Sales is pushing you to arrange access in specific markets. Compliance with global regulations is essential to launch your products successfully. Incomplete or inaccurate documentation will delay market access for several months. The optimal and most efficient approach hinges on factors like your device's characteristics, diverse regulatory requirements, classification, local rules and requirements, available resources, and timelines.
Qserve offers expert guidance to navigate these complexities, ensuring your device meets all requirements for a smooth and efficient global market entry. It is essential to do it the first time right, providing upfront, clear requirements and meeting deadlines to accelerate and increase time to market. We have a dedicated team that is passionate about global market access, and they walk the extra mile to get your devices to the market fast and compliant.
Successfull registrations
Market access covers the initial registrations and legal representation necessary in many markets:
Global Registrations
We understand the requirements for every country and provide you with a roadmap for access based on your available documentation and/or existing market approvals. We ensure faster time to market by doing registrations right the first time.
Legal Representation
Many markets require local legal representation. Our dedicated team is ready to act as your legal representative. We understand when, what, and how to communicate with the authorities. Our expertise guarantees continued compliance.
Outsource Market Access
If you do not have enough capacity or your team has to focus on other priorities, we can support and provide flexible resources.
Regulatory Intelligence
We understand that staying up-to-date with ever-changing regulations can be daunting and time-consuming. That's why we've developed Qserve InSight, our innovative platform designed to keep you updated with regulations, guidance, standards, and regulatory news feeds.
Training
Advance Your Expertise with Qserve Learn—dedicated Training for the MedTech and IVD Sectors. Anytime, Anywhere.
Use experts to prevent loss and inefficiency by ensuring faster time to market. Understand what is expected, avoid costly delays, and do it right the first time. Use expertise for reliable and practical solutions to ensure compliance avoid costly delays. We ensure compliance, reduced risks, and smooth market access. Qserve walks the extra mile for their customers. We recognize the urgency your team faces in achieving rapid market access. By integrating our specialized expertise into your operations or outsourcing your market approval process to us, you'll accelerate the time-to-market for your devices across multiple countries.
