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SYMBIOTEQ

Your Medical Device
QA/RA Specialist

As medical consultants, we help our clients develop, maintain management systems and technical documentation adapted for their operations.

Medical Technology Operations

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/MDR, IVDR, ISO 13485, ISO 9001, ISO 14971, ISO 10993, IEC 60601, EN 62366, IEC 62304, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.

Customer benefit and customer value

SAFETY

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.

EFFECTIVENESS

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.

QUALITY

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.

COMPETENCE

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.

Our Services

Specific competences

Symbioteq’s overall competence is broad, but at the same time
very specific. Press the button below to access an overview of our services and read more about how we work.

Training

Find trainings and courses

Contact us

Stockholm (Headquarters)

Gothenburg

In the current global situation, the health and safety of our employees, customers and partners is our first priority.

Symbioteq will comply with the regulations and follow the official Swedish recommendations on how to minimise risk of spread of the virus. We hope you will understand and respect this decision.

Although we will not always be in the office, Symbioteq employees remain at work. We will do our utmost to support our valued clients moving their projects forward. If you have any questions then do not hesitate to call or e-mail relevant Symbioteq employees.

Kind Regards

Jan Hellqvist
CEO
Jan.hellqvist@symbioteq.se
+46 705 61 25 19