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ABOUT SYMBIOTEQ

We work mainly in the niche
Medical Technology

The company is located in Stockholm and Gothenburg

About us

Symbioteq was established in 1994 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 management systems and technical documentation adapted to their operations. This objective still characterizes the company today.

The name Symbioteq is an acronym for the symbiosis between technology and quality (SYMBIOsis between TEchnology and Quality). It was originally formed as a reaction to the type of reactive quality work that we were seeing all-to-frequently where, at the end of the project, a development team became aware of the regulatory requirements that they should have taken into account both during the project and for the product documentation. Such an approach leads to extensive, time-consuming and thus costly work that must suddenly be performed just when the organization thought it was prepared for an imminent launch.

In 2001 Symbioteq became a limited company with headquarters in Stockholm. Today the company also has an office in Gothenburg.

We work mainly in the medical device niche, but can also apply the same philosophy to other Life Science disciplines as well as to caregiving.

Symbioteq also takes steps to improve our world by supporting ECPAT, which works against the trafficking of children, the Children’s Cancer Foundation, UNICEF and Missing People.

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.

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

FDA Application

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

trainings

Symbioteq provides trainings in regulatory affairs and quality assurance for people in the medical device industry.

management system

For the medical device manufacturer, a quality management system is a regulatory requirement.

Choose from our courses & conferences

Educate with Symbioteq

Symbioteq offers both public and company-specific training for those who work with quality and regulatory issues in medical technology operations.

Management

Name
Title
Email
Antonia Claasz
Regulatory Affairs
antonia.claasz@symbioteq.se
Monica Grekula
Biological and Clinical
monica.grekula@symbioteq.se
Åsa Möllby
Quality Management System
asa.mollby@symbioteq.se
Anders Norrbrand
Active Devices
anders.norrbrand@symbioteq.se
Julia Sidenlund
Head of Office
julia.sidenlund@symbioteq.se
Jan Hellqvist
CEO
jan.hellqvist@symbioteq.se

Data privacy

Handling of Personal Data

In contact with Symbioteq Kvalitet AB the personal data included in your email will be used for the purpose of the content of your mail.
Symbioteq Kvalitet AB will handle your personal data in accordance with data protection legislation. We will only retain your personal data for as long as necessary for the stated purpose, while also taking into account our need to answer queries or resolve problems and to comply with legal requirements under applicable laws.
This means that we may retain your personal data for a reasonable period after your last interaction with us. When the personal data that we collect is no longer required in this way, we destroy or delete it in a secure manner.

The responsible party for handling the personal data is Symbioteq Kvalitet AB. If you wish to receive information regarding handling of your personal data please send a written request to Symbioteq Kvalitet AB, Box 1251, 131 28 Nacka Strand or mail info (at)symbioteq.se. We will distribute the information to you without charge. You also have the right to request a change of incorrect or misleading information as well as have your data deleted (as long as the personal data is not required for other reasons, e.g. legal requirements).