Symbioteq Kvalitet AB
Europe, Canada and USA.
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.
Areas of regulatory/reimbursement support:
Symbioteq helps medical device companies with all issues within regulatory affairs and quality assurance. This spans from helping start-ups with regulatory support, planning, performing QA/RA work, workshops and education to development and implementation of quality management systems in large medical device companies. We have long experience from working with eHealth products (From large electronic health record systems to small mobile platform applications) and have assisted both class I, class IIa and IIb manufacturers. Symbioteq is your partner for all matters relating to MDD, MDR, AIMD, IVDD, IVDR, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366-1, IEC 62304, IEC 82304-1, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.