Compliance Engineering
for successful standards compliance
As an experienced development partner in the future markets of medical technology and life science, our services also include professional compliance engineering. Our focus is on ensuring that your developments comply with the applicable standards and that you receive the necessary approvals for your products.
MDR & FDA
Our interdisciplinary team makes it its core task to carry out these developments in accordance with the relevant standards. We always work closely with our customers to meet all application-specific, technical and economic requirements. At the same time, we always keep an eye on CE approval in accordance with the Medical Device Regulation (MDR) and the requirements of the FDA.
EN ISO 13485
The EN ISO 13485 standard regulates the structure of a medical technology company's quality system and ensures that your processes are defined accordingly. At DMTpe, we are not only experts in consulting, but also have ourselves regularly certified by DQS to ensure that the EN ISO 13485 standard is always adhered to within our processes.
Competences of our team
Our experienced team has extensive expertise and is able to meet the specific requirements of a wide range of standards. We rely on thorough verification of technical requirements through internal testing and cooperation with accredited testing laboratories. This enables us to demonstrate compliance with the relevant standard specifications for you, be it through EMF tests, climate tests, biocompatibility and cytotoxicity tests or the verification of and compliance with isolation distances.
Our team has a strong focus on the development and engineering process, ensuring that applicable standards are identified and adhered to.
You can rely on our experienced engineers to ensure that your products comply with the standards and that you receive the necessary approvals.
