Integrity: The Core of Our Partnership
In a highly regulated environment like the medical device industry, trust is the most valuable currency. Due to my work at Matern Consulting and my concurrent role as a reviewer for Notified Bodies (NBs), I carry a significant responsibility. To ensure the absolute impartiality of my assessments and the integrity of my consulting services, I have established clear ethical guidelines for my professional activities.
Maintaining Independence: The Separation of Consulting and Review
Strict adherence to compliance requirements protects both my clients and the integrity of the regulatory system. Therefore, the following principles apply:
Product-Specific Separation
I provide strategic consulting or drafting of Clinical Evaluations exclusively for product groups for which I am not authorized as a reviewer by the respective Notified Bodies.
Manufacturer Exclusion
Manufacturers whose Clinical Evaluations I review on behalf of a Notified Body, as well as their direct competitors, are ineligible for my individual consulting services (document drafting, strategic consulting).
Public Knowledge Transfer
Seminars and Public Events
The transfer of expertise through public seminars and lectures is exempt from these restrictions. As these activities focus on general regulatory requirements and methodological approaches, they are open to all manufacturers – regardless of any concurrent reviewer activities.
In-house Training
Under the MDR, in-house training sessions are classified as consulting activities. Therefore, these sessions are only
offered to manufacturers of products for which I am not authorized as a reviewer by Notified Bodies.
Your Advantage: Legal Certainty
This transparency provides you with the assurance that the documents created for you are built on a sound legal foundation. Before starting any project, I conduct a thorough assessment for potential conflicts of interest. This assessment is also continuously performed by the Notified Bodies. Together, we ensure that your project is never jeopardized by future questions of bias or partiality.