To further strengthen our growing team of experts and increase our presence in Europe and the US, Qserve is pleased to welcome several new colleagues.
Jan van Lochem, CEO of Qserve Group: As a global medical device consultancy, we continue to grow our staff and expand our range of knowledge and experience, thus creating a global partner for our clients. Our strong international team, with Regulatory, CRO, Quality and Training competencies, is able to offer our clients access to international markets for a multitude of medical devices."
New additions to the Regulatory Affairs team are Ashwini Kulkarni & Samuel Golub.
As a Regulatory consultant of the non-active Medical Device Regulatory team, Ashwini has hands-on experience in various medical device projects for regulatory submissions, including: writing dossiers, technical writing, gap analysis, query handling, conducting literature-based studies, project coordination, and support. Her regulatory experience is with implantable devices, devices utilizing biological tissue (animal/human) and devices which incorporate ancillary medicinal substances. As a Regulatory consultant, Samuel assists manufacturers who are seeking access to the European and American markets for their medical devices. His specific interests lie in navigating the challenges arising from the interplay between manufacturers and the global marketplace.
Samuel says: “Qserve really is a huge pool of clinical, regulatory and quality knowledge with different people representing different subspecialties within those groups. However, what I like most about Qserve is the approach towards clients: closely assisting clients with guidance from the design and development stage to final product marketing and beyond, but also helping clients to solve intermittent issues and problems. Either way, we always aim for warm and fruitful relationships built to last!”
New addition to the Clinical Affairs team is Femke Valkenburg.
Before joining Qserve’s Clinical Affairs team, Femke obtained her Masters in Neurosciences,
and is currently completing her PhD
. During this time, she has used various medical devices and worked within the regulations concerning animal experimentations. Her areas of interest include:
medical writing, literature searches, arranging clinical studies, investigating/analyzing clinical data, and clinical strategy development.
New additions to the Quality Assurance team are Nadira Salah & Rania Gerges.
With her B. Eng and MSc, Nadira has gained a broad interdisciplinary knowledge in various fields of Biomedical Engineering, including medical science, medical devices, software programming, tissue engineering and regenerative medicine. Besides her biomedical engineering background, she has previous experience in designing, implementing, and executing various projects, as well as training healthcare professionals.
As a Quality Assurance Consultant, Rania has extensive hands-on experience in successful delivery of quality engineering results. She has lead activities such as: design control cycle, risk management, sterilization, biocompatibility and shelf life studies, design verifications, process validations, test method validations, sampling plans, CAPAs, NCs, post-market surveillance, and internal and supplier audits.
Rania says: “I am honored to be part of a global medical device consultancy team highly skilled in the field of regulatory affairs and compliance, quality management system, auditing, clinical affairs and training. I am excited about this rewarding career journey, in which I contribute to Qserve’s mission to help improve patient safety and health through supporting the advancement of medical devices companies. This move will not only sharpen my current skills, but it gives me an opportunity to develop new ones in the innovative field of medical devices.”