Certifications according to DIN EN 13485

Your key to quality assurance in the medical device sector

Advice and preparation

We are at your side right from the start and help you plan and prepare for your certification. We analyze your processes and support you in implementing the necessary quality management systems.

Document management

Preparing the necessary documentation is an essential step on the way to certification. We support you in compiling all the necessary documents and ensure that everything complies with the DIN EN 13485 requirements.

Audit preparation

We prepare your company thoroughly for the upcoming certification audit. Our experienced auditors carry out internal audits to ensure that you are optimally prepared.

Implementation of the certification audit

We accompany you during the official certification audit and are at your side throughout the entire process to ensure that everything runs smoothly.

Continuous improvement

Quality doesn’t stop after certification. We help you to continuously improve your quality management system and meet the requirements of DIN EN 13485.

Rely on our many years of experience and expertise in the field of DIN EN 13485 certifications. We pride ourselves on helping our customers achieve the highest quality standards in the medical device industry.

Contact us today to find out more about our services and to plan your path to medical device certification together.