At Qserve, we take pride in our team of highly skilled professionals who are committed to delivering high-quality clinical documentation. Today, we are excited to introduce you to Dulce Aguilar, who has obtained extensive experience over the past years in clinical evaluation of medical devices, EU MDR compliance, medical writing, project coordination, and medical device prototyping.
In 2021, Dulce joined Qserve as a medical writer. Her main activities are within the clinical evaluation process, including literature search and appraisal for the creation of clinical evaluation plans and reports. With her attention to detail, and strong scientific and technical writing skills, Dulce delivers sound, structured and compliant clinical documentation.
Dulce has over 9 years experience in post-graduate research, driven to improve patient well-being through the advancement of medical technology. She has a strong technical background in manufacturing and precision engineering. After earning a BSc degree in Mechatronics in 2009, she started her research career by pursuing a MSc in Manufacturing and later concluded her PhD in Ultra Precision Engineering with a focus on Tissue Engineering and 3D Printing. Having expertise in diverse fields allows Dulce to look at problems from a broader perspective.
Significant Challenges in Medical Writing
When asked what one of the most significant challenges is in medical writing today, Dulce answered:
“The growing complexity and specificity of regulatory requirements under the EU MDR. Each medical device presents a unique profile -defined by its classification, intended use, target patient population, and clinical claims- which directly influences the type and depth of evidence required for compliance. As a result, generic approaches are no longer sufficient."
At Qserve, we help clients navigate this complexity by crafting clinical evaluation strategies tailored to the distinct characteristics of their devices. Whether it’s designing a robust literature search plan or determining the appropriate amount and sources of clinical evidence, we guide clients toward the most effective and defensible path to regulatory compliance.
A True Asset to Our Team
Based in the UK, Dulce is the go-to person for the preparation and review of Clinical Evaluation Plans and Clinical Evaluation Reports (MEDDEV 2.7.1/rev. 4 and EU MDR), as well as preparation of Literature Search Protocols and Data Collection Reports (MEDDEV 2.7.1/rev. 4 and EU MDR).
Our goal is to to ensure every document is not only technically rigorous, but also strategically aligned with both regulatory expectations and the device’s market positioning. If you are looking for a reliable partner to support you during any phase of clinical documentation, contact us today!