Choose the expertise that fits your needs
Working with a global team of experts, Qserve manages a diverse array of projects in the medical device industry. Together, we bring your medical device to the global market, complying with international regulations and assuring product quality and safety.
Regulations vary depending on the medical device and market you wish to enter. Our teams support you with global challenges in Regulatory Affairs and Quality Assurance worldwide.
We support all of your pre-CE clinical studies and Post-Market Clinical Follow-up (PMCF) challenges. Together we will secure sufficient clinical evidence to satisfy the regulator.
On-the-job training, developing internal audit programs, setting up quality systems for start-ups, assistance with management review processes and interim QA-Management.
In-house knowledge of regulatory and quality requirements facilitates the product-to-market process and provides insight into clinical safety and