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Extensive experience provides effective and safe result. Mediteq
Mediteq was initiated in 2007 by Helen Sandelin and has now grown to become a small-sized consulting firm with great ambitions. Helen Sandelin’s experiences in medical devices and systems goes all the way back to 1995, which constitutes a solid foundation for Mediteq and its advance.
Mediteq has representation in two of Sweden’s committees that develop international standards:
IEC Technical Committee 62 -
handles standards connected to medical electrical equipment
ISO Technical Committee 355 -
handles standards connected to quality management system for medical devices
The involvement in these standardization groups, makes Mediteq a player in the front row when it comes to updates, amendments and changes to existing standards, as well as knowledge of and information about new standards, and what effect 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 initiated on the initiative of the Swedish Medical Products Agency (MPA), and aims at increasing the transparency and exchange of information and experiences between MPA and consulting firms within the medical device industry. We are also a member of the Regulatory Affairs Professional Society (RASP), which is an international organization for regulatory affairs experts within 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.
Mediteq has among others gained experiences in working with the following products;
  • 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
In addition, Mediteq operates a network of knowledge - Mediteq Forum.
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Mediteq Svenkebo AB
Kanalstråket 1, SE-433 76 Jonsered
+46 31 774 25 00