Regulatory Affairs

Compliance with all regulatory requirements, known as Regulatory Affairs, is of fundamental importance for the approval and marketing of medical devices and in vitro diagnostics. With the introduction of the European legislation – the EU-MDR / IVDR – manufacturers, importers and distributors face new challenges. But don't worry! Our experts will support you in meeting the necessary requirements and completing the registration process successfully.

Product classification

What is the difference between a medical device and other products? What risk class does it have or should it have?

Technical documentation

Essential for medical devices - but what must be considered in the technical documentation?

Risk management

Risk management for medical devices has been significantly expanded in the MDR. We support you with the implementation.

Biocompatibility

When does the biocompatibility of a medical device have to be proven? What methods are available? We will be happy to advise you.

Sterilisation / Sterility

Which processes are best suited for which medical devices and what are the requirements?

Approval of medical devices

Internationally, each market has its own approval requirements for medical devices. We are at your side.

Product classification

If you intend to place a medical device on the market, the classification of the device is the most important issue that needs to be clarified first. Precise clarification of the intended purpose in advance can avoid unnecessary effort and delays in the approval process. We are happy to provide you with expert and detailed advice and help you determine the right classification for your medical device.

Technical documentation

The technical documentation covers the entire life cycle and provides all the required evidence. It is the core of a medical device. Our experts help you to create a comprehensive documentation thus achieving a hassle-free approval. We support you in this planning process. Rely on our expertise and experience to meet all required regulatory requirements!

Risk management

Documenting your risk management is an essential part of your technical documentations as a medical device manufacturer. Preparing the risk management file, including the risk management plan, risk analyses, and reports can be challenging. We offer comprehensive advice to help you with this. Our experts are available to help you implement an effective risk management.

Biocompatibility

When developing medical devices contacting or inserted into the human body, proof of the biocompatibility considering factors such as sterilisation method, material, and packaging is required. Our experts have this expertise and experience to help you meet all your required biocompatibility requirements. Rely on us to ensure safe and compatible product development as well as a compliant technical documentation.

Sterilisation / Sterility

We have extensive knowledge of the various sterilisation processes that can be used depending on the product and area of application. The variety of possibilities and requirements demand a high level of detailed knowledge. We will be happy to advise you in detail about the appropriate procedure for your specific requirements.

Approval of medical devices

What are the regulatory requirements for approval in different international markets? Our team has the knowledge and background information on the respective markets thus enabled to support you in meeting the necessary requirements for the target market. We help you to understand and implement the necessary regulatory steps to achieve successful registrations in the different markets.

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