With more than 25 years of experience in delivering reliable and practical solutions and swift responses to the MedTech industry, Qserve consultants guide you through complex regulatory pathways.
Reduce time-to-market with tailored solutions
While MD and IVD manufacturers develop medical technology or remediate their portfolio to meet the latest regulatory requirements, growing challenges are faced daily. MedTech innovation demands deep regulatory knowledge, robust quality systems, and strategic market insight in the rapidly evolving healthcare landscape.
At Qserve, we specialize in guiding startups, scale-ups, and established enterprises. We leverage our comprehensive expertise to help you drive products from the initial concept through to market access and continuous post-market support. We help minimize your business risks and reduce time-to-market with tailored solutions, all while maximizing your chances of success.
Satisfied Clients
Our consultancy covers multiple disciplines. Discover all of them:
Regulatory Strategy Support
We provide strategic guidance to help you develop a roadmap for regulatory compliance and market access tailored to your specific product and target markets.
Dossier Submission Support
We support or write to technical documentation and prepare for US FDA submissions or Notified body conformity assessments.
Interim Support
Whether you need temporary replacement of a QA/RA manager, regulatory expertise, project management, or technical support, our interim services provide the flexibility and expertise you need to succeed.
Clinical Strategy Support
Our services help you design and execute data-driven, risk-informed clinical pathways that align with both regulatory expectations and real-world evidence needs.
Medical Writing
The demand for accurate and compliant clinical (evaluation) documentation has become paramount as the healthcare industry continues to evolve. At Qserve, we understand the critical role of effective medical writing and perform clinical evaluations.
QA Support
We specialize in delivering quality assurance services tailored to meet the diverse needs of the medical device and in-vitro diagnostic industries.
Use expertise for reliable and practical solutions to ensure compliance avoid costly delays. At Qserve, we support you through our practical approach, blending extensive knowledge with hands-on industry and notified body experience. This allows us to deliver customized, efficient solutions that meet real-world business requirements. We ensure compliance, reduced risks, and smooth market access.
