Services

The regulatory one-stop-shop for medical device compliance

Services

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.

 

 

  

Regulatory Affairs

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.

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Clinical Trials

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. 

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Quality Assurance

On-the-job training, developing internal audit programs, setting up quality systems for start-ups, assistance with management review processes and interim QA-Management.

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Training Academy

In-house knowledge of regulatory and quality requirements facilitates the product-to-market process and provides insight into clinical safety and performance.

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How can we help you? Contact us