Expertise Field

International support with Clinical Studies and Clinical Evaluation

There is a worldwide trend towards more emphasis on clinical data for regulatory submissions. With the new MDR/IVDR the notified bodies will ask for more and more clinical data. The experience is that there is more emphasis on clinical proof of claims & intended use. Customers need to proof to Notified Bodies the underlying data, risk analysis, and rationales.

Clinical Consultancy

  • Clinical development plan
  • Sufficient Clinical Evidence
  • MDR readiness and implementation
  • Clinical Evaluation Plan (CEP)
  • Literature review
  • Clinical Evaluation Report (CER)
  • MEDDEV 2.7/1 rev.4 compliance
  • Clinical problem solving
  • Training
  • Clinical Audit
  • Worldwide support

Interim Clinical Support

  • Temporary support
  • Replacement
  • On-site or remote
  • Clinical department development
  • Coaching and training
  • Clinical Study Management
  • Site Monitoring
  • Alignment with QA/RA and marketing roles

CRO services

  • ISO 14155 / GCP compliance
  • Pre-CE study design and management
  • PMCF study design and management
  • Define Study Endpoints
  • Protocol/CIP development
  • Investigator Brochure (IB)
  • Case Report Form (CRF)
  • Informed Consent (ICF)
  • CA/EC submission
  • Site selection, training and management
  • Monitoring
  • Statistics
  • Data management
  • EDC system selection
  • Audits
  • Remediation of non-compliant studies

Our Regulatory - Clinical team

Qserve understands the additional needs to comply with the regulatory requirements requested by the MDR / IVDR. Qserve can prepare a plan based on your existing data, a practical plan using the solutions provided in the MDR / IVDR.

Our strength is in the combination of Regulatory and Clinical expertise. Starting on the basis of your regulatory strategy we scope together with you the clinical plans. A starting point is your current intended use, risk analysis data, and available as well as planned clinical data.



"With over 15 years of experience in medical device development, both in the pre-market and post-market setting, I know what it takes to effectively plan and execute clinical trials. I have reviewed many clinical evaluations and clinical trial results as a former notified body reviewer. I consider my broad knowledge and experience in both regulatory and clinical fields essential in clinical strategy decision making. Plotting a successful clinical strategy together with a client is probably the most satisfying part of my job."
Anna Pietersma, Head Clinical Affairs

What we can do for you?

Clinical Evaluation

Qserve supports medical device manufacturers with their Clinical Evaluation during distinct phases of product development, underpinned by risk management activities.  

Medical Device CRO

We provide study designs and, investigational plans, and aid in institutional review board and regulatory submission processes.    

Post-market Clinical Follow-Up

We offer a post-market surveillance strategy that fulfills regulatory requirements and enables product innovation.