Interview with Qserve's consultant Wiebe Postma
1. What does a typical Qserve working week look like?
Every week is different. Recently, I spent 2 days developing a post-market clinical follow-up (PMCF) plan for a manufacturer with an implant that was on the marked based on equivalence. I also spent a full day on remote site assessments with doctors who were interested in participating in a pre-CE study with a stent, a project currently being managed by Qserve. The remainder of that week was spent on miscellaneous work, including a gap assessment on a customer’s clinical evaluation report (CER) for a novel cancer treatment, updating various procedures in our quality management system (QMS), and follow-up of ongoing clinical trials.
2. How would you describe your work experience as a consultant in the clinical department with Qserve?
The work is very diverse and always changing. There is always something new to learn. Our clinical department supports a wide range of projects, and a considerable portion of our time is devoted to our work as a contract research organization (CRO). Qserve manages clinical studies with devices ranging from class I products to high-risk implantables, and from pre-CE early feasibility studies to confirmatory post-market clinical follow-up (PMCF) studies. Additionally, we work on clinical evaluations and clinical strategies. We really strive to help our customers in their data collection and getting their devices to the market.
3. What is your specialization?I come from a background of clinical operations in the medical device industry. I focus in clinical evaluation of non-active implantable devices, clinical risk management, and the start-up of clinical studies. Want to know more? Please check my profile.
4. What do you hope your position contributes to the team?
We have a small team in which everyone has a different background. Each person brings his or her own unique experience, and together, we offer a full range of services and expertise that make Qserve an ideal partner. I would say that I have a good feeling for the practical implementation of a clinical study at research sites, and I hope that I bring to the team a sense of understanding of the research site experience, and the importance of relationship management with the physicians with whom we work.
“I strongly believe in the value of a practical and user-friendly approach while ensuring a high standard of quality. I look forward to helping customers bring their products to the market efficiently in an increasingly demanding regulatory environment. Does your medical device lack clinical data? We can help determine how to efficiently close those gaps and support your clinical investigations.”
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