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.
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.
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.
has among others gained experiences in working with the following products;
- ECG and patient monitoring
- Electronic Medical Records (EMRs)
- Sterile products
- Care beds
- Communication- and alarm system
- Products for IVF
- Several types of analytical software
In addition, Mediteq operates a network of knowledge - Mediteq Forum.