At Qserve, we are fortunate to have a team of highly skilled professionals who are committed to strengthen your clinical evaluation process. Today, we proudly present you to Patrícia da Silva Pérez, Senior Consultant and Manager of our Medical Writing team. Given her expertise in both biomedical science and engineering, she is acquainted with explaining complex technical information in a clear and accessible way for different audiences, while complying to clinical and regulatory requirements.
Patrícia has a strong academic background as a former scientist, with a BSc degree in Biomedical, a BEng degree in Mechanical Engineering, and MSc and PhD degrees in Biochemistry. Before joining Qserve in 2021, Patrícia has gained hands-on experience in the medical device industry in designing and implementing systematic literature searches, clinical evaluations, biocompatibility-related documentation, toxicological analysis and the biological and clinical modules of eCTDs.
Her expertise lies in designing, planning, executing, and reporting biological and clinical technical documentation, as an experienced medical writer. Patrícia actively supports the implementation of technical documentation with a focus on the CE target market, but also for other regulators, such as FDA (USA), TGA (Australia), ANVISA (Brazil) and considering MDSAP programs. In addition to her technical strengths, Patrícia manages the medical writing team, overseeing both day-to-day activities and the professional development of team members. She also leads the development of SOPs and best practices for the medical writing function, ensuring full alignment with current regulatory requirements.
Based in Brazil, Patrícia possesses an in-depth knowledge of the clinical documentation submission process. She has direct experience in legal manufacturer Notified Body audits (CE, FDA, MDSAP, ANVISA) resolving potential regulatory issues. Her knowledge and experience have contributed to Qserve’s strong track record of successful submission approvals. When asked how Qserve's Medical Writing team adapts to the evolving needs of clients, Patrícia answered:
"Qserve’s Medical Writing team maintains a continuous regulatory surveillance process and integrates updates directly into biocompatibility and clinical evaluation workflows, combining regulatory foresight and mastery of regulatory language. The team is mature enough to adjust the approach based on the data available for the device, seeking the most effective and more cost-efficient way to generate clinical evidence. It often involves recalibrating clinical strategies, refining systematic literature searches, or tightening clinical benefit/risk arguments as new data emerges.
In addition, as an active member of working groups (WGs) 1 and 4 from the ISO/ TC 194 - Biological and Clinical Evaluation of Medical Devices – I take part in the development of ISO standards (ISO 10993-1 (biological evaluation), ISO 14155 (clinical investigation) and the upcoming ISO/DIS 18969 (clinical)), which allows me to provide the team early warning and direction for the constant updates."
If you are looking to outsource the management of your clinical documentation or want expert guidance in developing compliant and value-driven documentation, Patrícia and the team are here to support you. Whether you need end-to-end professional medical writing support, or assistance with specific aspects, contact us today to learn how we can ensure the success of your submissions.