At Qserve, our strength lies in the expertise and dedication of our team, who ensure excellence in every piece of clinical documentation. Today, we’re pleased to introduce Jasmin Hunter – our Senior Consultant in Clinical Regulatory Affairs, with over 10-years of experience in designing and implementing Clinical Evaluation strategies for CE certifications for a variety of medical devices.
With a certificate in Technical Writing, their background in developing technical files and clinical evaluations, and deep expertise in information and data management, Jasmin is a strong asset to our Medical Writing team.
In addition to their Medical Writing expertise, Jasmin brings more than 20 years of experience in generating and evaluating data for pharmaceuticals, In-vitro diagnostics, and medical devices. Over the course of their career, they have become highly skilled at defining performance and safety outcome parameters, making them an expert in designing clinical data collection strategies tailored to diverse markets.
Hands-on Experience and Expertise
Jasmin has developed an innovative methodology for identifying literature that minimizes irrelevant data. They also created a robust appraisal and data-extraction process that consistently meets the scrutiny and expectations of notified bodies under the MDR.
With hands-on experience in preclinical research design and implementation across cancer biology, immunology, and in vitro diagnostics, Jasmin is deeply familiar with the complexities of scientific evidence generation.
When asked what motivates Jasmin to work in clinical research and regulatory affairs, they answered:
"I have used scientific literature to guide research throughout my career. To me, scientific literature is a fortune teller; Its mysteries require excavation and patience. It is a process I have always enjoyed. I wish more people appreciated a well-designed literature search and it seems the EU MDR is forcing that wish on the MedTech industry.
My goal with every client is to help them understand a medical device from a patient and healthcare provider perspective and how that relates back to how the device is designed and manufactured. I enjoy finding ways to make data from literature quantifiable within the framework of regulatory requirements. I also enjoy telling the story about how data from all sources supports the performance and safety of the device."
Advice for MedTech companies looking to optimize their Medical Writing efforts
Jasmin suggests to involve a medical writer with experience in regulatory affairs early in the process when planning a submission. Medical writers are responsible for the data analysis of retrieved literature data, PMS data, risk management, PMCF, and clinical investigations. They will know best how to organize the information and present it in a way that facilitates a successful review.
In many cases a medical writer skilled in regulatory affairs can justify data currently available in response to regulatory agency inquiries, which saves time and money in the review process. If a justification is not possible, they will be able to suggest the most efficient method of data collection.
At Qserve, we see many clients struggling to effectively respond to notified body deficiency reports. Each failed attempt leads to less confidence from the notified body and a longer review process. Our medical writers are knowledgeable, skilled and successful in responding to notified body inquiries even if Qserve did not prepare the clinical evaluation.
A Valuable Member of Our Team
Based in Northern-East US, Jasmin plans and implements clinical evaluations while training clients on associated regulatory requirements. You may also see Jasmin as a speaker at industry conferences or webinars.
Do you need guidance in your Medical Writing process? Our team is always ready to support you.