Clinical Affairs

Your way to MDR-compliance

The transition towards the Medical Device Regulation (MDR) occupied the medical device industry for some years. The implementation of its requirements is the cornerstone of your products’ success. As a specialized service provider we understand the complexity and challenges that come with the shift from the MDD towards the MDR. novineon CRO accompanies you on your way towards the CE-certificate and beyond.

In addition to clinical evaluations our range of services also includes the following essential aspects of the MDR:

Post-Market Surveillance (PMS)

We offer you individual and pragmatic plans and reports for post-market surveillance of your products after market release, to ensure continuous safety and performance.

Mehr erfahren

Risk management and instructions for use (IFU)

We support you in optimizing the risk management of your products, to shape your instructions for use into MDR compliance and to harmonize your documents with the state-of-the-art.

Mehr erfahren

Biological evaluation

Biological evaluations fulfill all requirements of ISO 10993-1:2018. Each material of the product is reviewed qualitatively and quantitatively via database searches and a literature research. At the end you’ll have an evaluation of the biological risk and/or a confirmation of the biological safety of your product.

Mehr erfahren

Preclinical research

Our services include the implementation of design-verification, product-validation and usability tests.

Mehr erfahren

Change assessment/evaluation

Long transition periods and long validity of the MDD-certificates are all well and good – but what changes for Legacy Devices can be implemented under the umbrella of the prolonged MDD-certificates? We apply the applicable requirements to your individual product situation.

Mehr erfahren