Quick to market

You are developing a new device and want to bring it to market as fast as possible? We advise you on device classification, support you in the acquisition of your CE mark and answer your questions regarding device safety.

Your capable contact

• We provide you with device and portfolio analysis support.
• We help you to differentiate between medical devices and medicinal products if you are uncertain of how to classify a particular item.
• Are you interested in an optimum marketing authorisation and certification strategy? Feel free to ask us.
• We will point you along the most cost-effective path to your CE marking.

Scientific, strategic, regulatory

Do you have questions regarding materials, device safety or the state of the art? Are the materials you use safe?

• Are they biocompatible?
• Do the materials have to be tested?
• How do you navigate your way through the DIN EN ISO 10993-1 standard?
• What about the usability of your product?
• How do you get to grips with the DIN EN 60601-1 standard?
• Are your instructions for use written in clear language?
• Do you meet all the CE mark requirements?
• Are you familiar with the current standards that apply to your company and your device?
• Is your risk analysis up to date and in accordance with DIN EN ISO 14971?
• Does your quality management system work optimally according to DIN EN ISO 13485 and Quality System Regulation (QSR)?

We provide scientific, strategic and regulatory advice with regard to medical devices, in vitro diagnostics (IVD) and drug-related medical devices.

Keeping your staff up to speed

Naturally, we will also conduct training in your company. We adapt the material specifically to your needs.