What do we do?

Symbioteq performs consultations and offers guidance, training, and staffing for medical device companies. Our core value is patient safety, as well as protecting our clients’ and colleagues’ safety and security. Symbioteq was established in 1994, just as the medical device regulations were taking shape in Europe.
The company was formed not only to help our clients satisfy regulatory requirements, but with the objective of helping them develop and maintain quality management systems and product documentation adapted to their operations. This objective still characterizes the company today.

Symbioteq is your partner for all matters relating to MDD, AIMD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366, IEC 62304, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.


» ISO 13485:2016 is here

Do you need help on the way? We provide a GAP analysis.
» Read more…


Our services

CE marking

In order to sell a medical device in the EU, the product must be CE marked. The CE marking must be obtained by the responsible manufacturer. CE marking

FDA application

The medical device industry in the United States is monitored by the American Food and Drug Administration (FDA). FDA application

Management Systems and GAP Analysis

For medical device manufacturers a quality management system is a regulatory requirement. Management Systems and GAP Analysis

Due diligence

The medical device industry is tightly controlled by regulatory requirements. Due diligence

Biological and Clinical Evaluation

Biological and Clinical Evaluation reports are key documents in front of application for Clinical Trial or documentation needed for CE marking. Biological and Clinical Evaluation

Ongoing support

Symbioteq can give you guidance on everything from specific questions to continuous support in your ongoing business operations. Ongoing support

Customer benefits and added value


Symbioteq’s core value is patient safety. Our work is always characterized by the early identification of patient-related risks. Our vision is to support you as a company in the use of risk management for the identification of operational-related risks and use the results to make informed decisions.


Symbioteq is passionate about quality! Regardless of whether it’s about your products, your quality management system or our work, we set pride in always delivering advice, services and training of the highest quality.


Symbioteq delivers smart and efficient solutions. We do not sell a standard system or offer ready-made answers, but always customize our work around your business, your products and your specific requirements.


Symbioteq has the strongest team of consultants in quality assurance and regulatory compliance in the medical device industry. The collective expertise is broad, but the individual expertise is specific.


Your name (required)

Your email adress (required)


Your message