Symbioteq Kvalitet AB

– Your partner in Quality Assurance & Regulatory Affairs for Medical Devices

Symbioteq is a consultancy company within the Medtech field (IVD (in vitro diagnostic) as well as Medical Devices) and was founded back in 1994 by Tomas Camnell. We have offices in Gothenburg and Stockholm for the time being.  Core value for Symbioteq is patient safety, which of course also in most cases is of highest importance for companies producing medical devices.

Thanks to our wide experience and various in-depth competences in the regulatory and quality environment we can guide you to a fast and cost-efficient market entry.

Our services cover the entire development process from concept creation of new products to post-production activities, the services can roughly be divided into main areas consultancy services and education. We prefer to be involved early in the development to set the RA/QA-strategy together with the company, since late implementation of these issues often renders costly delays before market entry. The consultancy can be done on site as well as in Symbioteq facilities.

Examples of Consultancy services that Symbioteq provides:
• Regulatory strategy, including Product Classification
• Strategy for coming EU Regulatory Requirements
• Development of management systems (ISO 13485, QSR, ISO 9001 etc.)
• Internal audits
• Issue Technical file
• Product Registration USA, Canada, Australia etc.
• Development of or guidance in Risk Management process (ISO 14971)
• Development of or guidance in Usability engineering process (ISO 62366)
• Standard guidance, such as gap analysis and interpretation (IEC 60601-series, IEC 61010-series etc.)
• Establishing requirements, product and process (EU, USA and others.)
• Development of product documentation (labels, manual, etc.)
• Project management
• Regulatory expertise
• Act as QA / RA-staff and /or managers
• Regulatory due diligence
• Etc etc

Regarding education we can more or less tailor make any education according to our customers’ needs within the medical field, we also have partners (Intertek and key2compliance) where we have open educations.

Symbioteq have unique certification programs for individual persons (“QA/RA Leader Medical Devices” and “Auditor/Lead Auditor Pharmaceuticals/Medical Devices”) and offers separate education programs to prepare the participants in necessary skills to achieve the individual certification.

For further information regarding Symbioteq, see www.symbioteq.com

Contacts:
Tomas Camnell: +46 (0) 70 561 25 88 (mobile) tomas.camnell@symbioteq.se
Åsa Runnäs: +46 (0) 70 561 25 40 (mobile) asa.runnas@symbioteq.se

Augustendalsvägen 32, SE-131 52 Nacka Strand, Sweden
+46 8 621 05 02
http://www.symbioteq.com