With over 10 years of experience in the medical device industry, we specialize in both quality management systems and medical devices. Our team has worked with more than 15 different product types, giving us a broad and practical understanding of diverse technologies and regulatory requirements.

We provide tailored consultancy services, ranging from addressing specific, targeted questions to supporting complete projects that involve the development of technical documentation and quality management systems.

In addition, we offer internal audit services (onsite or remote), online training programs, and a convenient online shop where you can purchase document templates.

Our expertise also covers international standards and harmonized regulations related to medical devices, ensuring that our clients receive efficient, compliant, and up-to-date guidance for their projects.

Contact us and tell us about your needs or the scope of your consulting project. Your confidentiality is our priority. We are always ready to sign an NDA to ensure full protection of your information.

Evaluation

We will carefully evaluate the scope and feasibility of the consulting project. Shortly thereafter, we will provide you with a proposed budget and timeline.

Agreement

We will reach an agreement to conduct the project and make it a success!