Product analysis and regulatory support
We conduct a comprehensive product and gap analysis of your medical devices or in vitro diagnostics, identify the applicable legal basis and derive requirements for the level of evidence of the study.
Do you need help with the first steps towards the approval or reimbursability of a medical device? If required, we can also put you in touch with our reliable cooperation partners.
Embedding in the healthcare market
We analyze the positioning of your product in the healthcare market and develop needs-based solutions to ensure the success of your medical device or digital health application after a successful clinical trial.
Identification of relevant (groups of) stakeholders and users
We help you identify the most relevant target groups for your product and develop a product strategy tailored to your needs together in a workshop. In doing so, we focus on the needs of patients and physicians and keep the required levels of evidence in mind.
