We are pleased to announce that Michelle Hasse joined Qserve Group as a consultant, part of our Medical Device team, and a Regulatory/US Submissions Expert based in the US.
Michelle has gained much experience over the past eight years in medical device regulatory and clinical affairs with many companies, from small start-ups to large international device manufacturers.
“I love navigating complex regulatory landscapes and developing bench, animal, and clinical evidence-generation plans taking the least burdensome approach to meet unique situations.”
Within Qserve, Michelle focuses on US FDA premarket regulatory strategies and submissions, and has experience with products of all regulatory classifications. This includes radiological devices, electrosurgical devices, cryoablation probes, surgical mesh, and wearable monitoring devices.
Michelle’s
profile is available on the website, explaining her experience and core competencies.
About Qserve Group Qserve's mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We guide manufacturers in gaining and maintaining compliance and conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve's global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years of combined expertise in the medical field. Teams in the EU, USA, and China provide a global footprint for global regulatory, clinical, CRO, and quality services.
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, or auditing in medical devices. Check our
current vacancies.