Healthcare and Medical Devices

EU MARKET ACCESS FOR MEDICAL DEVICES

TÜV SÜD Danmark ApS is the second EU MDR (Regulation (EU) 2017/745) Notified Body under TÜV SÜD. Providing services to medical device manufacturers globally, TÜV SÜD Denmark Medical Health Services‘ primary focus is to deliver a seamless and efficient certification experience by optimised processes. 

Our transparent communication and customer-centric approach supports you through an efficient regulatory compliance evaluation and market access journey for your innovative products. TÜV SÜD Denmark MHS focuses on efficient processes that deliver a seamless and efficient certification experience.

At TÜV SÜD Denmark MHS, we understand the transformative power of innovative medical devices and the lifesaving care they offer millions of patients throughout the world. We provide conformity assessments under the European Union’s MDR (Regulation (EU) 2017/745) for a variety of the following medical device groups, including: 

• Cardio
• Neuro
• Software
• Orthopaedic

Contact:   [email protected]

OUR OVERARCHING ESSENCE IS TO BE CUSTOMER CENTRIC

Find out more about the services we provide for the healthcare industry and medical device manufactures:

Your journey, our priority

Our approach to customer service revolves around understanding and anticipating your needs through open and honest communication, right from the start. Your point of contact will provide you with updates at regular intervals that suit you, keeping you informed and confident about the status of your project, so that you can plan for the future.

Predictable and transparent

We believe that predictability is more than just an expectation - it‘s a commitment. From the outset, we present a clear roadmap of the conformity assessment process by detailing the stages and expected timelines, while also setting mutual requirements and expectations. Our experienced team works diligently to achieve key milestones and deliver steady progress with the highest quality. To keep you informed, we maintain consistent communication, providing regular updates and progress.

Efficient Conformity Assessment

As your trusted Notified Body, we‘re committed to optimising timelines and upholding the highest standards of quality and compliance. Our streamlined processes and highly skilled team are geared to ensure an efficient conformity assessment. By meticulously planning and execution in every step of the process, we minimise potential delays.

• Medical Device Market Approval & Certification 

• Complaints & Appeals
• Vigilance
• Independence and Impartiality Declaration