Clinical and Performance Evaluation is certainly one of the most critical topics for medical device manufacturers in Europe.

The MDR and IVDR have set many new requirements and navigating them requires a lot of strategic thinking, experience in the subject, and technical capacity to execute what is needed in order to demonstrate safety and performance.

At confinis, we have developed our own recipe to serve clients, that we could summarize in the following 5 points:

  1. Top researchers at your service – by working with confinis you will interact with our clinical evaluation team, composed of individuals with doctorates from the most prestigious Swiss and European institutions. And here is the unsurprising news: smart people normally come up with smart answers!
  2. We understand the business – our personnel is very diverse: we have personalities that managed corporate divisions, SMEs, startup founders, but also people that worded for Notified Bodies, competent authorities and even former FDA investigators. In other words, by working with us you will be able to capitalize on experience from both “sides” of the fence
  3. We talk tech – our clinical evaluation team includes innovators and engineers, and is able to effectively interface to your development team: our goals is to bring you the niche skills you need to address specific issues, solve your problems, and help you achieve your goals! You will be surprised about the amount of topics and indications we can cover
  4. Staying up-to-date – all employees at confinis receive in-depth training on Regulatory and Quality affairs, creating a unique pool of competences that will make the difference in your submission
  5. Crafters of quality – when you work with us, you will discover our passion: for every project, we create customized solutions based on the needs of our clients. Our consultants can integrate into your team and participate to an enriching dynamic whose ultimate goal is always the same: success! One plus one sometimes can make three

Feel free to reach out to us if you want to know more or to book an appointment:

The confinis team