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Extensive experience provides effective and safe result. Mediteq
Mediteq was founded in 2007 by Helen Sandelin and has now grown to become a small-sized consulting firm with high ambitions. Helen Sandelin's experience in medical devices and systems goes back to 1995 and constitutes a solid foundation for Mediteq.
Mediteq has representatives in two Swedish committees that develop international standards:
IEC Technical Committee 62 -
standards regarding medical electrical equipment
ISO Technical Committee 355 -
standards regarding quality management system for medical devices
ISO Technical Committee 334 -
standards regarding Health informatics for medical devices
The involvement in these standardization groups, puts Mediteq in the front line when it comes to updates, amendments and changes to existing standards, as well as knowledge of and information about new standards, and the affect these might have on the medical device industry.
Mediteq is also a member of MEDEA, a professional association for consultants within the medical device industry. MEDEA was started on the initiative of the Swedish Medical Products Agency (MPA) and works for increased transparency and exchange of information and experience between MPA and consulting firms in the industry. We are also a member of the Regulatory Affairs Professional Society (RAPS), which is an international organization for regulatory affairs experts in the medical device industry.
Our clients are large international organizations, small- and medium-sized enterprises, companies that undergo internal development, start-ups, as well as organizations within health care.
Below is a selection of products we have been working with;
  • ECG and patient monitoring
  • Electronic Medical Records (EMRs)
  • Ventilators
  • Sterile products
  • Care beds
  • Communication- and alarm system
  • Products for IVF
  • Implants
  • Several types of analytical software
  • Wound care products
  • IVD including software
  • PPE
In addition, Mediteq runs a knowledge network - Mediteq Forum.
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Mediteq Svenkebo AB
Kanalstråket 1, SE-433 76 Jonsered
+46 31 774 25 00