Services
Clinical evaluations
Clinical evaluation is mandatory for every medical device – from Class I to Class III – according to Article 61 and Annex XIV of the MDR. It is the core of the technical documentation and determines approval and market access.
At medXteam, your clinical data is our focus. That's why we offer two approaches to clinical evaluation – with the same high quality standards, but different levels of collaboration: We can create your clinical evaluation entirely for you – or we can support you in creating it yourself.
Two paths to your clinical assessment
Both approaches adhere to the same quality standards – auditable and compliant with notified bodies. The only difference lies in the level of collaboration, what you do, and what we do.
Option 1 – Creation by medXteam (complete package)
You will not only receive a document, but a fully audit-proof and Notified Body-compliant clinical evaluation file.
From strategy (CEP) and literature research to the finished CER including benefit-risk assessment – we handle the entire process.
Route 2 – Guided Clinical Evaluation (guided self-study)
You write your clinical evaluation yourself – we provide modular support exactly where you need it.
Individually bookable modules, depending on your actual needs – determined in a free initial consultation.