Absolute Medical GmbH
Your reliable partner for medical device approval and certification
The production and distribution of medical devices require stringent approvals and certifications. As a certified company, we work closely with DQS Medizintechnik GmbH (Frankfurt) and meet the requirements of DIN EN ISO 13485:2016.
Our commitment to service quality is evident in the validation of all production-relevant processes, ensuring compliance with current regulatory standards. This guarantees that your products consistently meet the necessary quality standards.
With years of experience in quality management and regulatory affairs, we provide comprehensive support for all matters related to the approval and certification of your medical devices. We guide you through the complex requirements and regulations of the industry with expertise.
Responsible Person for Regulatory Compliance according to Article 15 of MDR 2017/745 (EU):
Phone: +49 (0) 176 78111086
Rely on our expertise – for safe and certified medical devices.