We are pleased to announce that Celien van Lochem has joined Qserve as a business development specialist for our CRO services.
Qserve is a global consultancy company for quality, regulatory and clinical advice, training and auditing. Besides, we offer full CRO services, from pre-market clinical trials to post-market PMCF studies.
The new EU MDR regulations require medical device manufacturers to actively plan and execute PMS activities among with PMCF studies. For well-established products in the market, it is not always realistic to conduct a full PMCF study. Therefore, Qserve has developed alternative cost-effective PMCF surveys which are compliant with the regulations and standards such as ISO 14155. This is a cost-effective and pragmatic way of collecting clinical post-market data.
If you want to know what your options are and what Qserve can do for you, our CRO team will be happy to guide you in the right direction. As an experienced account manager in the healthcare space, Celien is driven to discuss with manufacturers how Qserve can help with clinical studies, PMCF studies or surveys. Her goal is to help you obtain the quality and amount of data needed to satisfy the regulatory requirements. Celien will be looking forward to reaching out to you and discuss how we can help you!