Blog

Armêl Plaine joins Qserve

Qserve Group is pleased to announce that Armêl Plaine has joined our team to further expand its capabilities in supporting the clinical and medical device industries worldwide.

Armêl Plaine is an experienced professional of over 14 years in clinical investigations with medical devices. After obtaining a PhD in microbiology, Armêl joined a European CRO specialized in Medical devices (MedPass International) where she held CRA, study manager roles and headed the Clinical Regulatory department. Armêl has developed expertise on clinical investigations with high-risk devices at different Clinical development stages (First-in man/Exploratory, Confirmatory to Observational Studies) and complex regulatory environment (Early Feasibility study and RCT under FDA regulation, sham control, patients in emergency situation, MD with drug or animal origin tissue) in a wide variety of medical indications. Armêl combines hand-on experience in clinical operation including Start-up activities and comprehensive knowledge Clinical investigation.

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 serve to guide manufacturers in gaining and maintaining compliance as well as 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’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides 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

Armêl Plaine, PhD
Veröffentlicht am:: Juni 21, 2021
Tags
Haben Sie Fragen oder benötigen Sie weitere Informationen? Kontaktieren Sie uns. Wir freuen uns auf Ihre Anfrage. Kontaktformular