• Regulatory Affairs
  • Medical devices

Medical devices

We are your partner for medical devices: from demarcation reports to certification.

Your challenge as a manufacturer is the regulatory classification of your product. Is it a medicinal product or medical device? You need to know this at an early stage of development as both product categories are subject to different legal frameworks in Europe.

When certifying medical devices, our focus is on strategic consultation to implement MDR requirements. This also includes revising QM processes and setting up or amending the QM system.

The portfolio of products we support covers medical devices of risk class I to III as well as combination products.

 

 

 

 

 

#medicinalproducts

Our services:

Differentiation and classification reports

Medicinal product or medical device? The legal framework conditions are entirely different for these two product categories.

Even for combination products it is necessary to clarify which directive regulates the product.

Benefit from our experience in

  • Preparing demarcation reports to submit to the authorities or nominated bodies
  • Discussion and decision-making in demarcation issues for your product
Technical dokumentation

Does your medical device meet the fundamental requirements in Europe? You evidence this with technical documentation.

The International Medical Device Regulators Forum (IMDRF) has published a recommendation as a guideline, “Summary Technical Documentation – STED”, for the structure of technical documentation.

We prepare, update and evaluate your technical documentation.

Biological safety

The evaluation of biological safety is a main component of the essential requirements of medical devices.

In addition to biocompatibility results you can also use and assess data and test results from the literature or clinical application. If you wish, we will evaluate the data and prepare the required report.

 

Risk analysis

Risk analysis is a vital part of the development and certification of medical devices. It compares the benefits of your device with the possible risks. Biological and clinical risks are included in the analysis along with technical factors.

We can help you with this: we can prepare your risk analysis, especially with regard to biological and clinical safety.

Clinical evaluation

As a manufacturer you have several ways of demonstrating the clinical efficacy of your product: using literature data or your own clinical tests.

We check for you which route is possible, feasible or necessary for your product and agree the process with you. And, if you wish, we can prepare both the clinical evaluation and study concepts for clinical testing. PMCF studies are included.

Support with certification

In the early phase of your project it is important to contact the nominated body. If everything is addressed at this point in time, development work will head in the right direction – for successful certification of your product.

Upon request, we can take over the following tasks for you:

  • Contact with the nominated bodies
  • Scientific consultations
  • Support with certification
  • Review of your documentation
  • Development of your product

Dr. med. Christian Schübel
Clinical Affairs / Medical Devices

Phone: +49 89 2000203-52
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0