Consulting Services

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Everything from a single source: Our support services for all product types, management systems, and markets

With over 100 experts, we are ready to support you in all regula­tory matters relating to your medical and IVD medical devices, tailored to your individual require­ments. 

Our team of experts is familiar with all legal requirements and appropriate methods, and even actively contributes to developing new standards, so we know exactly how to do everything right. 

With us, you benefit not only from proven concepts that really work in practice but also from a partner whose expertise is recognized and valued by authorities and notified bodies. 

Market Access/Regulatory Affairs

Our team helps you gain a foothold in all markets worldwide with your medical and IVD medical devices and make the right strategic decisions in regulatory affairs. 

 

Technical Documentation

We help you ensure that your technical documentation is complete and compliant, enabling you to pass the approval and review process for your medical and IVD medical devices quickly and safely.

 

Management Systems

We support you in setting up, continu­ously improving, and integrating management systems for maximum productivity and minimal audit stress. 

 

Change Management

Our experts support you and your company in your digitalization and transformation projects in regulatory affairs.

 

Assisted Self-Service

With our self-service solutions, we aim to support startups and manufacturers with limited budgets in overcoming regulatory hurdles on their own.

We are always there for our customers

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