Qmed Case Study:
"EU prospective study evaluating the efficacy and safety of a novel medical device" The European-based sponsor of the study initially categorised the product as a pharmaceutical product, but during the clinical strategy process it was revealed that the product should be classified as a medical device.
We provide full-service medical device CRO services to people who change advance revolutionize healthcare.
Our expertise throughout the product life cycle:
Regulatory, Product development, Strategic planning, Concept and product development, Market Access
Regulatory, Quality Management, Concept and product development
Regulatory, Quality management, Clinical, Concept and product development
Regulatory & Clinical
Clinical and Reimbursement
Your partner for medical device clinical research.
At Qmed Consulting we believe that the only way to ensure the best solution for all concerned is to base our recommendations and activities on the real needs of our clients.
Our focus is on supplementing your own expertise and competences, not replacing them. That means that when you partner with us you can be sure that we will only propose activities for which you either do not have sufficient resources, or that you would prefer us to accept responsibility for in order to free up your own resources for other tasks.
Best-in-class knowledge and experience from the medical device experts.
We offer strategic consulting services based on best-in-class knowledge, experience and competences from a result-oriented and highly motivated team of international medical device strategic advisors, CRO specialists and commercial healthcare experts. Our clinical team are experts in monitoring and designing studies to ISO14155 and GCP.
Our purpose is to be part of the team that successfully paves the way for new medical device approvals that enable more efficient procedures while improving patient safety, outcomes and quality of life, thus helping inventors and investors achieve success.
See how we can help you